Cleared Traditional

K151476 - Beactive Brace (FDA 510(k) Clearance)

Class I Physical Medicine device.

K151476 · Natures Pillows, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
269d
Days
Class 1
Risk

K151476 is an FDA 510(k) clearance for the Beactive Brace. Classified as Orthosis, Limb, For Back Pain (product code PMV), Class I - General Controls.

Submitted by Natures Pillows, Inc. (Trevose, US). The FDA issued a Cleared decision on February 26, 2016 after a review of 269 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Natures Pillows, Inc. devices

Submission Details

510(k) Number K151476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2015
Decision Date February 26, 2016
Days to Decision 269 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 115d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PMV Orthosis, Limb, For Back Pain
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.