FDA product code OMW

Adhesive Backed Thermal Skin Patches

Physical Medicine·Class 1·21 CFR 890.5710
US regulatory classifications
US Product Code (FDA)
OMW
View Product Code Classification →
US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 890.5710
View CFR Regulation →
Medical specialty
Physical Medicine
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

Search keywords
About this record

Adhesive Backed Thermal Skin Patches is a medical device type in the Physical Medicine specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.