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Orthosis, Limb, For Back Pain

FDA product code PMV · 1 cleared devices

Class 1 Physical Medicine
Regulation
21 CFR 890.3475
Review panel
PM
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
Yes
Clearance span
2016-02-26 – 2016-02-26

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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