Musclesense II Clinical Electromyography Device

FDA 510(k) K970051 · Smith and Nephew Donjoy, Inc.

Substantially Equivalent

510(k) numberK970051

Submission

Device name
Musclesense II Clinical Electromyography Device
Applicant
Smith and Nephew Donjoy, Inc.
Carsbad, CA, US
Received
January 7, 1997
Decision date
July 10, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HCC – Device, Biofeedback
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

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Questions and answers

When was Musclesense II Clinical Electromyography Device cleared by the FDA?

Musclesense II Clinical Electromyography Device (K970051) received a 510(k) decision of Substantially Equivalent on July 10, 1997, 184 days after the submission was received.

What is the product code of K970051?

The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.