# K102190: Winstim

- Pathway: 510(k) (Special)
- Applicant: Johari Digital Healthcare, Ltd.
- Decided: Mar 17, 2011 after 226 days
- Product code: IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Winstim: named in the summary without a submission number

## Most influential descendants
- K130052: Tone-a-Matic (2013), 0 descendants of its own

## Indications for use
Tone-A-Maticis indicated to be used for Russian and EMS for: Symptomatic relief of chronic, intractable pain. Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increase local blood circulation Muscle re-education Maintaining or increasing range of motion Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. TENS for: Management of pain associated with post-traumatic or post-operative conditions.

Source page: https://510kreport.com/device/K102190
Methodology: https://510kreport.com/methodology