# K062453: Kingly Star Powered Muscle Stimulator, Model KS-138

- Pathway: 510(k) (Traditional)
- Applicant: Kingly Star Intl. Technology Co., Ltd.
- Decided: Apr 17, 2007 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 K031310 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031310: Tai Sheng Various Neox Powered Muscle Stimulator, Tai Sheng Electrical Machinery Co., Ltd. (2004) Summary page 1.

## Indications for use
Specific indications: used to apply an electrical current to electrodes on patient's skin to function as: * Relaxation of muscle spasms * Prevention or retardation of disuse atrophy * Muscle re-education * Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis * Maintaining or increasing range of motion Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.

Source page: https://510kreport.com/device/K062453
Methodology: https://510kreport.com/methodology