IOD
11 FDA 510(k) clearances · Product code
18 daysmedian time to decision
43 days90th percentile
11clearances measured
FDA profile
- Official device name
- Components, Exercise
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5350
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1992: 1 · 1994: 1 · 1998: 1 · 2017: 144 · 2018: 15
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 |
|---|---|---|
| DELUXE TRACTION EXERCISE GLOVE BK5035 (K831544) | Fred Sammons, Inc. | 1983-06-24 |
| SURGICAL TUBING (K823648) | Fred Sammons, Inc. | 1983-01-21 |
| ANKLE WEIGHTS (K823822) | Danek Medical, Inc. | 1983-01-14 |
| SOLID WOOD CONE (K823600) | Fred Sammons, Inc. | 1982-12-22 |
| COLOR CODED WEIGHT CUFFS (K813632) | Fred Sammons, Inc. | 1982-01-19 |
| THERAPY BENCH (K812319) | Kaye Products, Inc. | 1981-08-31 |
| CANVAS WEDGE (K790587) | Maddak, Inc. | 1979-04-03 |
| SANDBAGS, VARIOUS WEIGHTS (K772414) | Fred Sammons, Inc. | 1978-02-01 |
| FLEXION MITTENS (K771030) | Stat Medical Corp. | 1977-06-27 |
| HAND SCREW CLAMP (K761118) | Fred Sammons, Inc. | 1976-12-02 |
| SHEET METAL CLAMP (K761119) | Fred Sammons, Inc. | 1976-12-02 |
Track IOD automatically
Every clearance here is in the API, with alerts when new ones post.