FMR
5 FDA 510(k) clearances · Product code
27 daysmedian time to decision
46 days90th percentile
5clearances measured
FDA profile
- Official device name
- Device, Transfer, Patient, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6785
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2005: 2 · 2006: 2 · 2009: 5 · 2013: 8 · 2019: 15 · 2026: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SOLOLIFT - PATIENT TRANSFER STRETCHER (K871475) | Adel Medical , Ltd. | 1987-05-11 |
| THE COMFORT LIFT (K801796) | Gettner Enterprises, Inc. | 1980-08-13 |
| TENDERLIFT (K800373) | Competent Design | 1980-03-12 |
| SKIL-CARE TURN AND HOLD PAD (K792318) | Skil-Care Corp. | 1979-12-20 |
| PATIENT TURNING AND REPOSITIONING G DEV. (K770499) | Patient Healthguards Corp. | 1977-04-29 |
Track FMR automatically
Every clearance here is in the API, with alerts when new ones post.