# K151476: Beactive Brace

- Pathway: 510(k) (Traditional)
- Applicant: Natures Pillows, Inc.
- Decided: Feb 26, 2016 after 269 days
- Product code: PMV (Orthosis, Limb, For Back Pain)
- Device class: 1
- Regulation: 21 CFR 890.3475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K821582 (1982). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K821582: Warm'n Form Sports Supports, Jerome Medical (1982) Summary page 4.

## Indications for use
The Beactive Brace is applied to the to the upper calf just below the knee such that the pressure pad presses against the soleus muscle located just to the outside of the back of the knee for the purpose of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities.

Source page: https://510kreport.com/device/K151476
Methodology: https://510kreport.com/methodology