# K013768: Powered Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Theratech, Inc.
- Decided: Jul 3, 2002 after 232 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
Longest line of descent: 1 generation back to K951951 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951951: Focus Model 795 Unit, Empi (1996) Summary page 1.
- K003596: Smith & Nephew Restim, Smith & Nephew, Inc. (2001) Summary page 1.
- K002874: Well-Tens, Well-Life Consultant (2001) Summary page 1.
- K002219: Wandy Self-Adhesive Neurostimulation Electrode, Wandy Rubber Industrial Co., Ltd. (2001)

## Indications for use
As an NMES device, the Ttech NMES is indicated for the following conditions: 1. Relaxation of muscle spasms 2. Prevention OF retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and 6. Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K013768
Methodology: https://510kreport.com/methodology