Panels › Physical Medicine › Product code IRQ · Class 1
Unit, Heating, Powered
Regulation 890.5950
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in IRQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet Microfixation, LLC | 0 | 1 |
| Ferno | 1 | 0 |
| Fred Sammons, Inc. | 1 | 0 |
| Marda Medical, Inc. | 1 | 0 |
| Thermowave Medical Device Corp. | 1 | 0 |
| Tri W-G, Inc. | 1 | 0 |
| Tru-Eze Mfg. Co., Inc. | 1 | 0 |
| Whitehall/Div Columbus Mckennon Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 2005 | K050524 | EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 Marda Medical, Inc. | IRQ |
| Mar 24, 1995 | K950350 | THEMALATOR. MODELS T-4-S, T-8-S, ETC. Whitehall/Div Columbus Mckennon Corp. | IRQ |
| Apr 14, 1993 | K924023 | FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 Ferno | IRQ |
| May 6, 1988 | K880644 | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) Fred Sammons, Inc. | IRQ |
| May 2, 1986 | K861340 | R1750 AND R1424 POWERED HEATING UNITS Tri W-G, Inc. | IRQ |
| Dec 9, 1983 | K832177 | PULSAIR MODEL SP-1 Thermowave Medical Device Corp. | IRQ |
| Jul 28, 1980 | K801625 | THERMOLATOR HEATING UNIT Tru-Eze Mfg. Co., Inc. | IRQ |
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