# K943535: Model ME 300 Muscle Tester

- Pathway: 510(k) (Traditional)
- Applicant: Regulatory Strategies, Inc.
- Decided: Jun 25, 1997 after 1,070 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K832714 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881416: Myotrac, Thought Technology, Ltd. (1988) Summary page 1.
- K832714: Verimed Myoexorciser, Verimed Holdings, Inc. (1983) Summary page 1.

## Indications for use
ME300 is an electronic-device used to gather and display electrophysiological signals obtained from muscle activity. These signals are used in programs related to muscle re-education and relaxation training.

Source page: https://510kreport.com/device/K943535
Methodology: https://510kreport.com/methodology