FDA product code INN: Chair, Adjustable, Mechanical
INN is the FDA product code for chair, adjustable, mechanical. It is a Class I device, regulated under 21 CFR 890.3100 and reviewed by the Physical Medicine panel. FDA has cleared 26 510(k) submissions under INN, from 19 different applicants. The average 510(k) review took 52 days (median 24). FDA has posted 23 recalls for INN devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Chair, Adjustable, Mechanical |
| Device class | Class I |
| Regulation | 21 CFR 890.3100 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every INN clearance
Top INN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Able Generation, Inc. | 3 | 1993-01-29 |
| Kaye Products, Inc. | 3 | 1992-07-21 |
| Theradapt Products, Inc. | 2 | 1994-06-22 |
| Mednet, Inc. | 2 | 1986-08-14 |
| Fred Sammons, Inc. | 2 | 1981-09-11 |
14 more applicants have INN clearances. See the full list in Caduvo.
Most recent INN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945650 | Thames Valley Children'S Centre | SPIFFY | 1994-12-19 | 32 |
| K942397 | Theradapt Products, Inc. | THERADAPT HIGHCHAIR/STROLLER INSERT | 1994-06-22 | 34 |
| K930520 | Theradapt Products, Inc. | THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR | 1993-03-24 | 50 |
| K923750 | The Able Generation, Inc. | ABLE GENERATION BOOSTER CHAIR | 1993-01-29 | 185 |
| K923752 | The Able Generation, Inc. | ABLE GENERATION PLAY CHAIR | 1993-01-29 | 185 |
Recalls for INN devices
23 product recalls in 11 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2026-01-05.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2022 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code INN?
INN is the FDA product code for chair, adjustable, mechanical. It is a Class I device, regulated under 21 CFR 890.3100 and reviewed by the Physical Medicine panel.
What device class is INN?
Class I, regulation 21 CFR 890.3100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code INN?
Across 26 cleared submissions the average was 52 days from receipt to decision (median 24).
Which companies have the most INN clearances?
The Able Generation, Inc. (3); Kaye Products, Inc. (3); Theradapt Products, Inc. (2); Mednet, Inc. (2); Fred Sammons, Inc. (2).
Have INN devices been recalled?
Yes: 23 product recalls across 11 recall events; the most recent began 2026-01-05.
Next steps
- Run an FDA pathway report with predicate devices for product code INN
- Run a recall and safety report across every INN manufacturer
- Watch product code INN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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