FMR — Device, Transfer, Patient, Manual Class I
FDA product code FMR covers "Device, Transfer, Patient, Manual", a Class I medical device regulated under 21 CFR 880.6785. Submissions are reviewed by the General Hospital panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FMR
- Device Class
- Class I
- Regulation Number
- 880.6785
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K871475 | Adel Medical | SOLOLIFT - PATIENT TRANSFER STRETCHER | May 11, 1987 |
| K801796 | Gettner Enterprises | THE COMFORT LIFT | Aug 13, 1980 |
| K800373 | Competent Design | TENDERLIFT | Mar 12, 1980 |
| K792318 | Skil-Care | SKIL-CARE TURN AND HOLD PAD | Dec 20, 1979 |
| K770499 | Patient Healthguards | PATIENT TURNING AND REPOSITIONING G DEV. | Apr 29, 1977 |