IRQ
7 FDA 510(k) clearances · Product code
80 daysmedian time to decision
246 days90th percentile
7clearances measured
FDA profile
- Official device name
- Unit, Heating, Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5950
- Medical specialty
- Physical Medicine
- Adverse events (MAUDE)
- 1994: 1 · 1996: 1 · 1998: 1 · 2008: 8
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 |
|---|---|---|
| EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 (K050524) | Marda Medical, Inc. | 2005-09-14 |
| THEMALATOR. MODELS T-4-S, T-8-S, ETC. (K950350) | Whitehall/Div Columbus Mckennon Corp. | 1995-03-24 |
| FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 (K924023) | Ferno | 1993-04-14 |
| ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) (K880644) | Fred Sammons, Inc. | 1988-05-06 |
| R1750 AND R1424 POWERED HEATING UNITS (K861340) | Tri W-G, Inc. | 1986-05-02 |
| PULSAIR MODEL SP-1 (K832177) | Thermowave Medical Device Corp. | 1983-12-09 |
| THERMOLATOR HEATING UNIT (K801625) | Tru-Eze Mfg. Co., Inc. | 1980-07-28 |
Track IRQ automatically
Every clearance here is in the API, with alerts when new ones post.