# K063642: FD Ems, Model # D-FJ30E

- Pathway: 510(k) (Traditional)
- Applicant: Fuji Dynamics Limited
- Decided: Dec 13, 2007 after 371 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 K031427 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031427: Electro Neuromuscular Stimulator, Model BMLS03-1, Biomedical Life Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K152676: FD Tens 2090, FD Tens 2095 (2016), 0 descendants of its own

## Indications for use
The FD EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for medical purposes, which repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following: - Prevention or retardation of muscle disuse atrophy; - Relaxation of muscle spasm; - Muscle reeducation; - Maintaining and increasing the range of motion; - Increasing local blood circulation; - Immediate post-surgical stimulation f calf muscles to prevent venous thrombosis.

Source page: https://510kreport.com/device/K063642
Methodology: https://510kreport.com/methodology