Product Code: MHW FDA class 1 21 CFR 880.5075

Dressing, Compression

General Hospital

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.

510(k)s
2
FEI Numbers
236
Registration Numbers
236
Unique Applicants
2
Years Active
16

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K070457 SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB
K912765 STASIS BUTTON PRSSURE DEVICE

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.