# K033544: Electrical Muscle Stimulator, Models N605 and N607

- Pathway: 510(k) (Special)
- Applicant: Everyway Medical Instruments Co.,Ltd
- Decided: Dec 10, 2003 after 30 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 K010665 (2001). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020750: Digital Electrical Muscle Stimulator, Model EV-807 Digital Ems, Everyway Medical Instruments Co.,Ltd (2002) Summary page 1.

## Most influential descendants
- K072795: Models Ems 5.0, Ems 5.1 (2007), 1 descendant of its own
- K091248: Maxems, Models 1000 and 2000 (2009), 0 descendants of its own

## Indications for use
Electrical Muscle Stimulator Series (Model Numbers N605, N607) 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/K033544
Methodology: https://510kreport.com/methodology