# K072795: Models Ems 5.0, Ems 5.1

- Pathway: 510(k) (Traditional)
- Applicant: Koalaty Products, Inc.
- Decided: Nov 27, 2007 after 57 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: 3 generations back to K010665 (2001). 3 ancestors in all.
1 later device descends 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)
- K033544: Electrical Muscle Stimulator, Models N605 and N607, Everyway Medical Instruments Co.,Ltd (2003) Summary page 1.

## Most influential descendants
- K091248: Maxems, Models 1000 and 2000 (2009), 0 descendants of its own

## Indications for use
Electrical Muscle Stimulator Series (Model Numbers EMS 5.0, EMS 5.1) 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/K072795
Methodology: https://510kreport.com/methodology