FDA product code PMV

Orthosis, Limb, For Back Pain

Physical Medicine·Class 1·21 CFR 890.3475
US regulatory classifications
US Product Code (FDA)
PMV
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 890.3475
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Medical specialty
Physical Medicine
Device characteristics
GMP exempt
Yes
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Intended to provide pressure to the soleus muscle for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.

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About this record

Orthosis, Limb, For Back Pain 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.