510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K151922Substantially Equivalent

StimSox(TM) System

Stimmed, LLC, Williamsville NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151922 is the FDA 510(k) clearance record for StimSox(TM) System, a class II device, cleared for Stimmed, LLC on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 2 510(k) clearances for Stimmed, LLC, from to . As of , FDA records show no recalls naming K151922.

Clearance record

Decision date
Received
(277 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Stimmed, LLC 388 Evans St., Williamsville NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260