Panels › Physical Medicine › Product code IMA · Class 1
Pack, Heat, Moist
Regulation 890.5730
0510(k)s in 12 months (8 all time)
0recalls in 12 months (9 all time)
0recalls that name a 510(k)
Top companies in IMA
| Company | 510(k)s | Recalls |
|---|---|---|
| Bruder Healthcare Company, LLC | 0 | 9 |
| Duro-Med Ind., Inc. | 1 | 0 |
| Electro-Med Health Industries, Inc. | 1 | 0 |
| Fred Sammons, Inc. | 1 | 0 |
| Maddak, Inc. | 1 | 0 |
| Rachel'S Remedies, LLC | 1 | 0 |
| Staodynamics, Inc. | 1 | 0 |
| Tru-Eze Mfg. Co., Inc. | 1 | 0 |
| Wahl Clipper Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 22, 2015 | K150139 | Rachel's Remedy Rachel'S Remedies, LLC | IMA |
| Mar 24, 1995 | K950701 | WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER Wahl Clipper Corp. | IMA |
| May 10, 1984 | K841698 | HEAT PACK Maddak, Inc. | IMA |
| Sep 20, 1983 | K832803 | STEAM PAK MOIST HEAT Electro-Med Health Industries, Inc. | IMA |
| Dec 30, 1982 | K823622 | INSULATED THERMOELASTOMER MITT Fred Sammons, Inc. | IMA |
| Dec 31, 1980 | K803177 | MOIST HEAT PACK Duro-Med Ind., Inc. | IMA |
| Sep 7, 1979 | K791653 | REUSABLE MOIST HEAT PACK Tru-Eze Mfg. Co., Inc. | IMA |
| May 18, 1979 | K790904 | STAO-HOTPACK Staodynamics, Inc. | IMA |
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