IMA
8 FDA 510(k) clearances · Product code
24 daysmedian time to decision
120 days90th percentile
8clearances measured
FDA profile
- Official device name
- Pack, Heat, Moist
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5730
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1998: 2 · 2002: 8 · 2004: 2 · 2008: 5 · 2009: 3 · 2014: 6
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 |
|---|---|---|
| Rachel's Remedy (K150139) | Rachel'S Remedies, LLC | 2015-05-22 |
| WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER (K950701) | Wahl Clipper Corp. | 1995-03-24 |
| HEAT PACK (K841698) | Maddak, Inc. | 1984-05-10 |
| STEAM PAK MOIST HEAT (K832803) | Electro-Med Health Industries, Inc. | 1983-09-20 |
| INSULATED THERMOELASTOMER MITT (K823622) | Fred Sammons, Inc. | 1982-12-30 |
| MOIST HEAT PACK (K803177) | Duro-Med Ind., Inc. | 1980-12-31 |
| REUSABLE MOIST HEAT PACK (K791653) | Tru-Eze Mfg. Co., Inc. | 1979-09-07 |
| STAO-HOTPACK (K790904) | Staodynamics, Inc. | 1979-05-18 |
Track IMA automatically
Every clearance here is in the API, with alerts when new ones post.