OMW · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.5710
Classification
FDA Product Code
OMW
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 890.5710
Review panel
PM
Medical specialty
Physical Medicine
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.