Paid acquisition into clinical and channel buyers
Which rehab and sports-medicine device categories are the most crowded?
A founder selling into physical therapy clinics, athletic training rooms or a team’s medical staff rarely competes with a whole review panel. The competition is the handful of companies selling the same kind of box to the same buyer: the compression unit on the recovery table, the stimulator in the kit bag, the anchor on the surgeon’s tray.
FDA files every cleared device under a product code, a three-letter label for one generic device type. Counting the separate companies clearing products under each code, in two windows seven years apart, gives a direct read on how many sellers are now chasing one buyer. That count is public, free, and rarely run at this level.
Which rehab and sports-medicine categories have the most competitors?
By distinct applicants in 2023-2025, the most crowded codes are permanent soft-tissue fixation with 37 and over-the-counter TENS with 36. Pneumatic compression massagers and muscle-conditioning stimulators follow with 30 each. Every other rehab code in the basket had 16 or fewer, and 12 of the 25 had fewer than five clearances in both windows.
That is a steep drop-off. Four codes hold most of the entry activity, and the rest of the rehab catalogue (diathermy, iontophoresis, traction, therapy tables, heating pads) sees zero to five filers per three-year window. A seller in one of the quiet codes faces a short list of rivals who have mostly been there for years. A seller in one of the four busy codes faces a list that turns over.
The basket as a whole grew from 231 clearances in 2016-2018 to 318 in 2023-2025, a rise of 37.7%. Three codes (soft-tissue fixation, compression and muscle conditioning) added 97 clearances between them, more than the basket’s whole net gain of 87.
Which categories are filling up fastest?
Pneumatic compression massagers went from 7 applicants to 30, a 4.3x increase, and from 8 clearances to 35. Muscle-conditioning stimulators doubled from 15 applicants to 30. Those two codes account for 38 of the basket’s net gain of 44 applicants. Permanent soft-tissue fixation added nine applicants while its clearances doubled from 50 to 101.
The compression code is the clearest case of a category changing character. In the earlier window it was a small specialist niche, seven filers with one or two products each. In the later window it holds 30 filers averaging 1.17 clearances each. That ratio matters. When clearances per applicant stay near one while the applicant count quadruples, the growth comes from new sellers.
The muscle-conditioning code behaves the same way, with a caveat worth knowing before reading too much into it. FDA’s device name is broad, and the code holds products sold for athletic recovery alongside products sold for body contouring. The applicant count is real. The share of those 30 applicants who sell to a training room rather than an aesthetics practice is not something this file can tell you.
Soft-tissue fixation moves the other way. Clearances rose 102.0% while applicants rose only from 28 to 37, so clearances per applicant climbed from 1.79 to 2.73. That is the signature of established filers clearing more variants.
Are the new applicants actually new companies?
Mostly, on the names as filed. In pneumatic compression, 27 of the 30 later applicants had no clearance in the code in 2016-2018, or 90.0%. In muscle-conditioning stimulators it is 29 of 30. Even over-the-counter TENS, which barely grew, replaced most of its field: 30 of its 36 later applicants are new.
The TENS result is the one a planner should sit with. Clearances went from 46 to 50, an 8.7% rise, and the applicant count moved from 33 to 36. On a panel-level view that code looks stable. Underneath, 83.3% of the applicants in the later window were not filing in it seven years earlier. A stable count of competitors is not the same as a stable set of competitors.
That churn has a commercial meaning. Buyers in a code with high turnover are evaluating names they have not heard before, every year. Brand recognition built five years ago buys less than it did, because the reference set the buyer compares against keeps changing. The data does not show incumbents being displaced. Many of them are simply not filing new products. The shortlist around them still turns over constantly.
Soft-tissue fixation shows the limit of the exact-name method. 31 of its 37 later applicants look new, 83.8%, yet the same code’s clearances concentrate in repeat filers. Part of the gap is spelling. Strip case, punctuation and company suffixes, and 3 of the code’s 37 later names collapse into another name on the list. The same test finds no duplicates in the compression, TENS or muscle-conditioning codes, so their new-entrant figures are cleaner. The method section covers why this inflates the new-applicant share in every code, and why it inflates it most where large filers are active.
Where are the new applicants based?
In the three consumer-facing electrotherapy and compression codes, the filing address moved to China. Pneumatic compression went from 12.5% of clearances filed from China to 68.6%. Muscle-conditioning stimulators went from 5.0% to 51.3%. Over-the-counter TENS went from 34.8% to 64.0%. Soft-tissue fixation stayed mostly US-filed, at 66.3% of later clearances.
The country field is the applicant’s address on the filing. It does not record the factory location or the market the product is sold into. Read narrowly, it says that the parties seeking clearance in these codes are increasingly based overseas. Read with the applicant counts, it says the new entrants in compression and muscle stimulation are mostly overseas filers bringing a first product to the US market.
The US share fell alongside. Pneumatic compression dropped from 62.5% of clearances filed from the US to 17.1%. Muscle-conditioning stimulators fell from 55.0% to 10.3%. The powered muscle stimulators sold into clinics held up better: 42.1% of that code’s later clearances are US-filed, and only 10.5% come from China.
The codes that sell mostly to consumers and athletes are where overseas filers arrived. The codes that sell mostly to clinics and surgeons, with a sales rep in the room, moved much less.
Why doesn’t the panel-level growth describe a PT clinic’s market?
Because most of it is wheelchairs. The panel-level analysis found Physical Medicine was the fastest-growing panel, from 184 clearances to 295. Of that net gain of 111, powered wheelchairs and motorized three-wheeled vehicles supplied 84, or 75.7%. Rehab-basket codes in the panel supplied a net 41.
Powered wheelchairs alone rose from 14 clearances to 75. Motorized three-wheeled vehicles rose from 9 to 32. Those products are bought through mobility dealers and home-equipment channels, not by a physical therapist equipping a clinic. A founder reading the panel headline as “rehab is getting crowded” would be reading a mobility story.
The rehab codes inside the panel tell a split story instead. Compression and muscle conditioning grew hard. Infrared heating lamps fell from 13 clearances to 3, and interactive rehab exercise devices went from 6 to none. Powered exoskeletons dropped from 8 to 5. The panel total averaged all of that into one number.
Both readings are true at their own level. The panel number answers “is this regulatory area busier”, and the product code answers “is the shelf this buyer shops from busier”. Only the second is a marketing question.
Which rehab categories are quiet, or thinning out?
The classic clinic modalities barely register. Ultrasonic and shortwave diathermy each had three or four clearances per window. Infrared heating lamps fell from 12 applicants to 3. Two basket codes, including water-circulating hot and cold packs, had no clearances in either window. Quiet codes mean incumbents defend a known shortlist.
Much of the installed equipment in these categories was cleared long ago and is still sold under those clearances. What a quiet code tells you is that few new sellers are paying to enter. The competitive set a clinic buyer sees is the one they saw last year.
That changes the job for a seller in one of these codes. The contest is about displacing an incumbent the buyer already trusts. Service, trade-in terms, and training support carry more weight there than awareness spending does.
The thinning codes raise a different question. When infrared lamps lose three-quarters of their applicants, either the category is consolidating, or sellers are routing similar products through a different code or pathway. The file shows the drop. It cannot show which of those two stories is behind it.
How was this calculated?
A basket of 25 product codes was chosen by device type before any counts were run: electrotherapy, heat and energy modalities, compression and massage, mechanical rehab, and soft-tissue fixation. For each code, one openFDA count of applicant names per window, 2016-2018 and 2023-2025. Data retrieved 2026-09-30.
The count returns every distinct applicant name with its number of clearances, so one request per code per window yields both the clearance total and the applicant count. New applicants are names present in the later window and absent from the earlier one, compared exactly as filed. Device names come from openFDA’s classification endpoint, which is also the source for what a product code is.
The panel decomposition is a separate count of product codes within the Physical Medicine panel for each window. The country mix is a count of the applicant country field for the six largest codes in the basket, in both windows. All three queries are recorded in the sources file, and all three result sets are downloadable above.
The windows match the panel-level analysis on purpose, so the two can be read side by side. Three-year blocks smooth out the administrative noise in single years, and the gap between them keeps the pandemic years out of both ends.
What can this data not tell you?
It cannot tell you who the buyer is. A product code groups devices by what they are. The same compression code covers a unit sold to a professional team and one sold to a weekend runner. The basket reflects Carmine’s judgment about which device types reach rehab and sports-medicine buyers, and a different judgment would produce a different list.
Applicant names are not normalised. A company filing under two spellings counts as two applicants, and a name that changed between windows counts as a new entrant. That inflates both the applicant count and the new-applicant share. Large filers with many clearances are the most likely to appear under several names, which is why the soft-tissue fixation figures should be read with the most caution.
The basket also leaves out most of what a sports-medicine buyer handles daily. Braces, supports, cold packs and many exercise devices are exempt from premarket notification and never appear in this file. A category can be crowded with sellers and invisible here.
A clearance is permission to sell. Some cleared products reach the market late, in one region, or never. A clearance count describes intent to sell. It says nothing about unit volume, price, or who is winning deals.
The new-applicant share counts only the code itself. A company new to compression may be a long-established electrotherapy seller extending its range. To the buyer that is still a new option on the shortlist, even though the company itself is established.
How do you run this for your own product code?
Two requests per code, no account. Find your product code on your own clearance letter or in openFDA’s classification endpoint, then count applicant names in each window. The number of results returned is your competitor count; comparing the two lists by name shows who arrived.
# distinct applicants under one product code, one window
https://api.fda.gov/device/510k.json?search=decision_date:[2023-01-01+TO+2025-12-31]+AND+product_code:IRP&count=applicant.exact&limit=1000
# where those applicants file from
https://api.fda.gov/device/510k.json?search=decision_date:[2023-01-01+TO+2025-12-31]+AND+product_code:IRP&count=country_code
# what a product code covers
https://api.fda.gov/device/classification.json?search=product_code:IRPRun the first request for both windows and compare the lists by eye. Merging obvious spelling variants by hand takes a few minutes for most rehab codes and removes most of the new-entrant inflation described above. For a code with dozens of applicants, sort both lists alphabetically before comparing.
Do it for the adjacent codes too. A clinic buyer shopping for a muscle stimulator may consider devices from two or three codes that FDA files separately. The shortlist the buyer builds does not respect FDA’s filing boundaries.
What should a founder in a crowded code do differently?
Plan for a shortlist that changes every year. In codes where most applicants are new, the buyer is comparing unfamiliar names on specifications and price. That rewards published specifications, comparison material, and proof of clinical support and service. It punishes a budget built on awareness alone.
The two crowded patterns call for different responses. In compression and muscle conditioning, the new sellers are mostly single-product filers entering from overseas. They compete on price and on marketplace visibility. A US seller’s better route is to be the obvious choice for the buyer who has something to lose: the athletic trainer answerable for a roster, the clinic owner who needs a service contract.
In soft-tissue fixation, the pressure comes from incumbents clearing more variants. That is a feature-parity fight. The surgeon’s tray fills with options that look alike. The seller who makes the comparison easy, with clear sizing, instrumentation compatibility and reliable supply, shortens an evaluation the buyer does not want to run.
In the quiet codes, the risk is complacency. Few new entrants means little external pressure to invest in demand generation. It also means a well-run challenger can take share from incumbents who have stopped competing for attention.
Two follow-ups are worth adding to a planning checklist. First, track where channel partners report leads coming from, because new overseas entrants often reach buyers through marketplaces rather than distributors. The lead-source schema for distributor channels is built for exactly that split. Second, rerun the count every year. Watch the direction and the turnover more closely than the absolute number.
Carmine’s view is that category crowding is the most underused input in a device marketing plan. It is public and cheap to check, and it moves before acquisition costs do. More on reaching clinical and channel buyers sits in the paid acquisition hub, and more on building authority in a crowded category in the category authority hub.