# K020750: Digital Electrical Muscle Stimulator, Model EV-807 Digital Ems

- Pathway: 510(k) (Abbreviated)
- Applicant: Everyway Medical Instruments Co.,Ltd
- Decided: Oct 31, 2002 after 238 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 K010665 (2001). 1 ancestor in all.
19 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010665: Transamerica Digital Ems, Transamerica Medical Systems (2001)

## Most influential descendants
- K071951: Comfy Series: EV-804, EV-805 & EV-806 (2007), 14 descendants of its own
- K082514: Tens/Ems Combo, Ems, Tens (2008), 6 descendants of its own
- K100117: LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator (2010), 4 descendants of its own
- K112288: Jiajian Tens (2012), 3 descendants of its own
- K102014: Tens Stimulator, Models 2800 and 3000 (2010), 3 descendants of its own

## Indications for use
EV-807Digital EMS is an electrically powered muscle stimulator intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for: - Relaxing muscle spasms. - Increasing local blood circulation. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - Muscle re-education. - Maintaining or increasing range of motion. - Preventing or retarding disuse atrophy

Source page: https://510kreport.com/device/K020750
Methodology: https://510kreport.com/methodology