Dressing, Compression
The Compression Dressing is a wound care product applied externally to exert controlled pressure on a wound or affected limb, commonly used to manage venous leg ulcers, edema, and post-surgical swelling. It is classified as a Class 1 device under 21 CFR 880.5075, meaning it is subject only to general controls, and it is generally exempt from the 510(k) premarket notification requirement. It falls within the General Hospital medical specialty and carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MHW
- Device Class
- FDA class 1
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Review Panel
- SU
- 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 236 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 236 registration numbers. Click on an entry to view related FDA registrations.