Pack, Heat, Moist
A Moist Heat Pack is a Physical Medicine thermal therapy device used to apply sustained moist heat to a body area, promoting muscle relaxation, increasing local blood flow, reducing pain, and facilitating rehabilitation. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IMA, regulated under 21 CFR 890.5730, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.
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Basic Information
- Product Code
- IMA
- Device Class
- FDA class 1
- Regulation Number
- 890.5730
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150139 | Rachel's Remedy | May 22, 2015 | Substantially Equivalent | Rachel'S Remedies, LLC |
| K950701 | WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER | Mar 24, 1995 | Substantially Equivalent | Wahl Clipper Corp. |
| K841698 | HEAT PACK | May 10, 1984 | Substantially Equivalent | Maddak, Inc. |
| K832803 | STEAM PAK MOIST HEAT | Sep 20, 1983 | Substantially Equivalent | Electro-Med Health Industries, Inc. |
| K823622 | INSULATED THERMOELASTOMER MITT | Dec 30, 1982 | Substantially Equivalent | Fred Sammons, Inc. |
| K803177 | MOIST HEAT PACK | Dec 31, 1980 | Substantially Equivalent | Duro-Med Ind., Inc. |
| K791653 | REUSABLE MOIST HEAT PACK | Sep 07, 1979 | Substantially Equivalent | Tru-Eze Mfg. Co., Inc. |
| K790904 | STAO-HOTPACK | May 18, 1979 | Substantially Equivalent | Staodynamics, Inc. |
FEI Numbers
This FDA classification entry is associated with 87 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 87 registration numbers. Click on an entry to view related FDA registrations.