# K034005: SDS-4I

- Pathway: 510(k) (Traditional)
- Applicant: Skylark Device & Systems Co., Ltd.
- Decided: Nov 18, 2004 after 330 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 K000114 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912642: EMS300, EMS400, EMS8000, Skylark Device Co., Ltd. (1991) Summary page 1.
- K992652: SD-730 IF-SDS, Perfect Pulse IF-SDS, Skylark Device & Systems Co., Ltd. (2000) Summary page 1.
- K032652: RS-4I Muscle Stimulator Family, Rs Medical (2003) Summary page 1.

## Indications for use
Indication Use for EMS (Code 10, 20-22,30-33) Only Relax muscle Spasms Prevent or retard disuse atrophy Maintain or increase range of motion Increase local blood circulation Re-educate muscle Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Indication Use for IF (Code 11-18, 20-22, 30-33) For symptomatic relief and management of chronic pain and /or as an adjunctive treatment in the management of post -surgical and post-traumatic acute pain. Powered muscle stimulators should only be used under medical supervision.

Source page: https://510kreport.com/device/K034005
Methodology: https://510kreport.com/methodology