FDA product code MOC: Cushion, Flotation, Therapeutic
MOC is the FDA product code for cushion, flotation, therapeutic. It is a Class II device, regulated under 21 CFR 890.5170 and reviewed by the Physical Medicine panel. FDA has cleared 2 510(k) submissions under MOC, from 2 different applicants. The average 510(k) review took 284 days (median 284).
Classification
| Field | Value |
|---|---|
| Device name | Cushion, Flotation, Therapeutic |
| Device class | Class II |
| Regulation | 21 CFR 890.5170 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MOC clearance
Top MOC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Technology Systems, Inc. | 1 | 2008-03-14 |
| Ergo-Air, Inc. | 1 | 1995-10-30 |
Most recent MOC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K063175 | Medical Technology Systems, Inc. | IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION) | 2008-03-14 | 512 |
| K954162 | Ergo-Air, Inc. | ERGOSEAT SYSTEM | 1995-10-30 | 55 |
Recalls for MOC devices
openFDA lists no recalls for product code MOC.
Frequently asked questions
What is FDA product code MOC?
MOC is the FDA product code for cushion, flotation, therapeutic. It is a Class II device, regulated under 21 CFR 890.5170 and reviewed by the Physical Medicine panel.
What device class is MOC?
Class II, regulation 21 CFR 890.5170. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MOC?
Across 2 cleared submissions the average was 284 days from receipt to decision (median 284).
Which companies have the most MOC clearances?
Medical Technology Systems, Inc. (1); Ergo-Air, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MOC
- Run a recall and safety report across every MOC manufacturer
- Watch product code MOC 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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