Product code PMV— Physical Medicine

Beactive Brace

Classification name: Orthosis, Limb, For Back Pain
Device class: Class 1
Regulation: 21 CFR 890.3475
Advisory panel: Physical Medicine
Total cleared: 1
First cleared: 2016-02-26
Most recent: 2016-02-26

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.”
— U.S. Food and Drug Administration, device classification record for product code PMV under 21 CFR 890.3475, via openFDA

Market context for product code PMV

FDA has cleared 1 device under product code PMV, all in 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code PMV

Natures Pillows, Inc.1 clearance

Recent clearances under product code PMV

K151476 — Beactive BraceNatures Pillows, Inc.·2016-02-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.