IMB
5 FDA 510(k) clearances · Product code
144 daysmedian time to decision
682 days90th percentile
5clearances measured
FDA profile
- Official device name
- Cabinet, Moist Steam
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5250
- Medical specialty
- Physical Medicine
- Adverse events (MAUDE)
- 2001: 1
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 |
|---|---|---|
| DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM (K003916) | Scandia Manufacturing , Ltd. | 2002-04-15 |
| DYNA T-2000 PHYSICAL THERAPY SYSTEM (K955808) | Thermia, Inc. | 1997-11-03 |
| SAUNETTE, PORTABLE STEAM CABIN (K914234) | Sauna Magic, Inc. | 1992-02-11 |
| HEATPAC (K810320) | Shinsei Corp. | 1981-03-04 |
| SANAR (K770086) | Health Improvement Assoc. | 1977-04-18 |
Track IMB automatically
Every clearance here is in the API, with alerts when new ones post.