Adhesive Backed Thermal Skin Patches
The Adhesive Backed Thermal Skin Patches (product code OMW) are Class 1 devices regulated under 21 CFR 890.5710 in the Physical Medicine specialty (PM), exempt from premarket notification. These over-the-counter heat patches are intended for temporary relief of muscular and joint pain associated with arthritis, backache, muscle strains, and sprains, and are applied directly to intact skin for up to 8 hours but no more than once per 24-hour period. The device is not an implant or life-sustaining, and should not be used on damaged skin, in children under 12, or by persons unable to perceive pain.
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Basic Information
- Product Code
- OMW
- Device Class
- FDA class 1
- Regulation Number
- 890.5710
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 74 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 74 registration numbers. Click on an entry to view related FDA registrations.