# K022998: Home Care Vareious Models of Powered Muscle Stimulator, HT-311, HT-311N, HT-312

- Pathway: 510(k) (Traditional)
- Applicant: Home Care Technology Co., Ltd.
- Decided: May 20, 2003 after 253 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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/K022998
Methodology: https://510kreport.com/methodology