FDA product code FMR: Device, Transfer, Patient, Manual
FMR is the FDA product code for device, transfer, patient, manual. It is a Class I device, regulated under 21 CFR 880.6785 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under FMR, from 5 different applicants. The average 510(k) review took 28 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Device, Transfer, Patient, Manual |
| Device class | Class I |
| Regulation | 21 CFR 880.6785 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every FMR clearance
Top FMR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Adel Medical , Ltd. | 1 | 1987-05-11 |
| Gettner Enterprises, Inc. | 1 | 1980-08-13 |
| Competent Design | 1 | 1980-03-12 |
| Skil-Care Corp. | 1 | 1979-12-20 |
| Patient Healthguards Corp. | 1 | 1977-04-29 |
Most recent FMR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871475 | Adel Medical , Ltd. | SOLOLIFT - PATIENT TRANSFER STRETCHER | 1987-05-11 | 27 |
| K801796 | Gettner Enterprises, Inc. | THE COMFORT LIFT | 1980-08-13 | 15 |
| K800373 | Competent Design | TENDERLIFT | 1980-03-12 | 21 |
| K792318 | Skil-Care Corp. | SKIL-CARE TURN AND HOLD PAD | 1979-12-20 | 31 |
| K770499 | Patient Healthguards Corp. | PATIENT TURNING AND REPOSITIONING G DEV. | 1977-04-29 | 46 |
Recalls for FMR devices
openFDA lists no recalls for product code FMR.
Frequently asked questions
What is FDA product code FMR?
FMR is the FDA product code for device, transfer, patient, manual. It is a Class I device, regulated under 21 CFR 880.6785 and reviewed by the General Hospital panel.
What device class is FMR?
Class I, regulation 21 CFR 880.6785. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FMR?
Across 5 cleared submissions the average was 28 days from receipt to decision (median 27).
Which companies have the most FMR clearances?
Adel Medical , Ltd. (1); Gettner Enterprises, Inc. (1); Competent Design (1); Skil-Care Corp. (1); Patient Healthguards Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FMR
- Run a recall and safety report across every FMR manufacturer
- Watch product code FMR 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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