510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K941049Substantially Equivalent for Some Indications

Musclemax Electrical Muscle Stimulator

Smith & Nephew, Inc., Carlsbad CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K941049 is the FDA 510(k) clearance record for MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K941049.

Clearance record

Decision date
Received
(73 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Smith & Nephew, Inc. 2777 Loker Ave., W., Carlsbad CA
Third party review
No

Clearances, product code IPF

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