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510(k) Data Aggregation
K Number
K151476Device Name
Beactive Brace
Manufacturer
Date Cleared
2016-02-26
(269 days)
Product Code
Regulation Number
890.3475Why did this record match?
Applicant Name (Manufacturer) :
NATURES PILLOWS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Beactive Brace is applied 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 purposes of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities. The Beactive® Brace is intended for over-the-counter distribution.
Device Description
The Beactive® Brace is a brace intended to temporarily reduce lower back pain that radiates down the leg associated with normal household or work activities. The Beactive® Brace is an adjustable, cylindrically-shaped band that fits over the upper calf on either leg. Integrated into the wall of the brace is a disk-shaped protrusion (pressure pad) that projects inward the leg. The pressure pad presses against the soleus muscle located just to the back of the knee. The pressure pad exerts even pressure on the soleus muscle near its origin at the fibula. The Velcro strap is designed to focus the pressure on the pressure pad on the calf. As a soleus muscle compression brace, it uses both compression as well as anterior glide forces onto the proximal tibiofibular joint to temporarily reduce low back pain.
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