Surface Electromyograph Biofeedback Muscle Activity Device

FDA 510(k) K954737 · J-Tech, Inc.

Substantially Equivalent

510(k) numberK954737

Submission

Device name
Surface Electromyograph Biofeedback Muscle Activity Device
Applicant
J-Tech, Inc.
Alpine, UT, US
Received
October 16, 1995
Decision date
July 3, 1996
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 Surface Electromyograph Biofeedback Muscle Activity Device cleared by the FDA?

Surface Electromyograph Biofeedback Muscle Activity Device (K954737) received a 510(k) decision of Substantially Equivalent on July 3, 1996, 261 days after the submission was received.

What is the product code of K954737?

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