510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970051Substantially Equivalent

Musclesense II Clinical Electromyography Device

Smith and Nephew Donjoy, Inc., Carsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970051 is the FDA 510(k) clearance record for MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE, a class II device, cleared for Smith and Nephew Donjoy, Inc. on under FDA product code HCC (Device, Biofeedback). FDA records list 15 510(k) clearances for Smith and Nephew Donjoy, Inc., from to . As of , FDA records show no recalls naming K970051.

Clearance record

Decision date
Received
(184 days to decision)
Product code
HCC Device, Biofeedback
Regulation
21 CFR 882.5050
Device class
Class II
Review panel
Neurology
Applicant
Smith and Nephew Donjoy, Inc. 2777 Loker Ave. W., Carsbad CA
510(k) summary
Summary
Third party review
No

Clearances, product code HCC

Trailing 12 months

FDA records hold no clearances under product code HCC in the trailing twelve months.

FDA records show no clearances under product code HCC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HCC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260