FDA product code OMW: Adhesive Backed Thermal Skin Patches

OMW is the FDA product code for adhesive backed thermal skin patches. It is a Class I device, regulated under 21 CFR 890.5710 and reviewed by the Physical Medicine panel. Devices under OMW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

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.

Classification

Recalls for OMW devices

openFDA lists no recalls for product code OMW.

Frequently asked questions

What is FDA product code OMW?

OMW is the FDA product code for adhesive backed thermal skin patches. It is a Class I device, regulated under 21 CFR 890.5710 and reviewed by the Physical Medicine panel.

What device class is OMW?

Class I, regulation 21 CFR 890.5710. Typical premarket route: 510(k) exempt.

Next steps

• Run an FDA pathway report with predicate devices for product code OMW
• Run a recall and safety report across every OMW manufacturer
• Watch product code OMW for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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