510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250896Substantially Equivalent

Aura Wave

Aura Wellness, LLC, Louisville KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250896 is the FDA 510(k) clearance record for Aura Wave, a class II device, cleared for Aura Wellness, LLC on under FDA product code SGT (Electromagnetic Stimulator For Healthy Muscle Stimulation). FDA's definition for product code SGT reads: "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...". FDA records list 2 510(k) clearances for Aura Wellness, LLC, from to . As of , FDA records show no recalls naming K250896.

Clearance record

Decision date
Received
(252 days to decision)
Product code
SGT Electromagnetic Stimulator For Healthy Muscle Stimulation
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Aura Wellness, LLC 2208 Plantside Dr., Louisville KY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SGT

Trailing 12 months
2 clearances under product code SGT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SGT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260