Product code PMV

Device name

Orthosis, Limb, For Back Pain

Medical specialty

Physical Medicine

Device class

1

Regulation number

890.3475

Review panel

PM

Implant

N

Life sustaining/supporting

N

GMP exempt

Y

Third party review

N

Summary malfunction reporting

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.

Source

FDA openFDA device classification dataset