← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS I

PMV — Orthosis, Limb, For Back Pain

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.

DEVICE CLASS
Class I
REGULATION
21 CFR 890.3475
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
PM
— Implant— Life-sustaining✓ GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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