# K972997: AM800 Automove Emg Triggered Electrical Muscle Stimulation

- Pathway: 510(k) (Traditional)
- Applicant: Dan Med, Inc.
- Decided: Nov 10, 1997 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.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053266: Myotrac Infiniti (2005), 4 descendants of its own
- K070425: Vitalstim Experia (2007), 2 descendants of its own
- K211094: Nerve and Muscle Stimulator (2021), 0 descendants of its own
- K153224: VitalStim (R) Plus Electrotherapy System (2016), 0 descendants of its own
- K120922: Guardian Dysphagia Dual Channel Nmes Unit (2013), 0 descendants of its own

## Indications for use
Stroke Rehab by Muscle Reeducation Relaxation of muscle spasms. Prevention of retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Maintaining or increasing range of motion.

Source page: https://510kreport.com/device/K972997
Methodology: https://510kreport.com/methodology