MOIST HEAT PACK
FDA 510(k) clearance K803177 · decided 1980-12-31
Clearance details
- K-number
- K803177
- Device name
- MOIST HEAT PACK
- Applicant
- Duro-Med Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-12-16
- Decision date
- 1980-12-31
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- IMA
- Device class
- 1
- Regulation number
- 890.5730
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| REUSABLE MOIST HEAT PACK (K791653) | Tru-Eze Mfg. Co., Inc. | 1979-09-07 |
| STAO-HOTPACK (K790904) | Staodynamics, Inc. | 1979-05-18 |
Recalls involving this device
No recalls on record reference this clearance.