Muscle Response Monitor

FDA 510(k) K971400 · Enriching Your Life

Substantially Equivalent

510(k) numberK971400

Submission

Device name
Muscle Response Monitor
Applicant
Enriching Your Life
Granbury, TX, US
Received
April 15, 1997
Decision date
April 14, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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 Muscle Response Monitor cleared by the FDA?

Muscle Response Monitor (K971400) received a 510(k) decision of Substantially Equivalent on April 14, 1998, 364 days after the submission was received.

What is the product code of K971400?

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