PMV

Orthosis, Limb, For Back Pain

Product code

PMV

Device name

Orthosis, Limb, For Back Pain

Device class

Class 1

21 CFR

21 CFR 890.3475

Medical specialty

Physical Medicine

Marketing pathway

510(K) Exempt

Flag

GMP exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).