Device, Pressure Applying
A Pressure Applying Device is a physical medicine device used to apply controlled pressure to specific body areas for therapeutic purposes, such as the management of hypertrophic scars, edema, lymphedema, or to facilitate wound healing following burns or surgery. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KNM and the applicable regulation is 21 CFR 890.5765 in the Physical Medicine specialty.
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Basic Information
- Product Code
- KNM
- Device Class
- FDA class 1
- Regulation Number
- 890.5765
- 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 63 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 63 registration numbers. Click on an entry to view related FDA registrations.