Cleared Traditional

K250896 - Aura Wave (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250896 · Aura Wellness, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
252d
Days
Class 2
Risk

K250896 is an FDA 510(k) clearance for the Aura Wave. Classified as Electromagnetic Stimulator For Healthy Muscle Stimulation (product code SGT), Class II - Special Controls.

Submitted by Aura Wellness, LLC (Louisville, US). The FDA issued a Cleared decision on December 2, 2025 after a review of 252 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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 Aura Wellness, LLC devices

Submission Details

510(k) Number K250896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2025
Decision Date December 02, 2025
Days to Decision 252 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 115d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SGT Electromagnetic Stimulator For Healthy Muscle Stimulation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
Definition A Device Used For Other Than Medical Purposes To Induce An Electrical Current To The Body Using A Time-varying Magnetic Field To Temporarily Increase Local Blood Flow And Stimulate Healthy Muscles. Unlike The Classified Powered Muscle Stimulator Devices Intended For Use In Physical Medicine And Rehabilitation, This Device Is Not Intended For Use In Patients With Medical Conditions.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.