Orthosis, Limb, For Back Pain

PMV · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3475

Classification

FDA Product Code: PMV
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 890.3475
Review panel: PM
Medical specialty: Physical Medicine
Submission type: 4
GMP exempt: Y
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 12

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown