Unit, Chilling
A Chilling Unit is a Physical Medicine device designed to cool a therapeutic pack, pad, or wrap to a controlled low temperature for application of cold therapy to the body, used in post-surgical recovery, acute injury management, and pain relief. 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 IMF, regulated under 21 CFR 890.5940, within the Physical Medicine medical specialty.
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Basic Information
- Product Code
- IMF
- Device Class
- FDA class 1
- Regulation Number
- 890.5940
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.