# K053266: Myotrac Infiniti

- Pathway: 510(k) (Traditional)
- Applicant: Thought Technology, Ltd.
- Decided: Dec 29, 2005 after 36 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: 2 generations back to K880235 (1988). 3 ancestors in all.
4 later devices descend from it; 2 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)
- K972997: AM800 Automove Emg Triggered Electrical Muscle Stimulation, Dan Med, Inc. (1997) Summary page 2.
- K031017: Sys*Stim 208 and 208A, Mettler Electronics Corp. (2003) Summary page 2.

## Most influential descendants
- 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
The MyoTrac Infiniti system is indicated for the ongoing treatment of the following conditions: Relaxation of Muscle Spasms, Prevention or retardation of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion and Stroke Rehab by Muscle re-education. It is also used for Biofeedback, Relaxation & Muscle Re-Education purposes.

Source page: https://510kreport.com/device/K053266
Methodology: https://510kreport.com/methodology