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OMWClass I

Adhesive Backed Thermal Skin Patches

21 CFR 890.5710 / Physical Medicine
FDA source (opens on fda.gov)

OMW is the FDA product code for Adhesive Backed Thermal Skin Patches, a class I device type, regulated under 21 CFR 890.5710. FDA's definition for this code reads: "Pain relief heat patches for temporary relief of muscular and joint pian assoiciated with arthritis, simple backache, muscle strains and sprains.External use only. Not on damaged skin or open sores. Do no use under the age of 12. Do use on people who are not able to feel pain. Patch is applied directly to site of pain...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OMW
Device name
Adhesive Backed Thermal Skin Patches
FDA definition
Pain relief heat patches for temporary relief of muscular and joint pian assoiciated with arthritis, simple backache, muscle strains and sprains.External use only. Not on damaged skin or open sores. Do no use under the age of 12. Do use on people who are not able to feel pain. Patch is applied directly to site of pain over intact skin for up to 8 hours but not more than once in a 24 hour period. Do not use more than 7 days. Over the counter device. No prescription. Do not sleep on or put pressure on heat patch for extended period of time. Do not use with any creams or oils. Can remove body hair upon patch removal due to adhesive. Can cause burns.
Regulation
21 CFR 890.5710
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 75 companies shown, in name order