Product Code: KNM FDA class 1 21 CFR 890.5765

Device, Pressure Applying

Physical Medicine

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.

510(k)s
2
FEI Numbers
63
Registration Numbers
63
Unique Applicants
1
Years Active
3

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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

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
K811956 AUTONORM & NERV-A-NORM
K780312 AUTONOM

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.