# K962462: Musclemax Plus Electrical Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Smith and Nephew Donjoy, Inc.
- Decided: Sep 23, 1996 after 90 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The MuscleMax™ Plus is a disposable single patient use EMS (Electrical Muscle Stimulator) intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Source page: https://510kreport.com/device/K962462
Methodology: https://510kreport.com/methodology