# K130052: Tone-a-Matic

- Pathway: 510(k) (Traditional)
- Applicant: Tone-A-Matic International, Inc.
- Decided: Dec 20, 2013 after 345 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 K102190 (2011). 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)
- K102190: Winstim, Johari Digital Healthcare, Ltd. (2011) Summary page 2.

## Indications for use
Tone-A-Matic is indicated to be used for * Russian and EMS for: o 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: o Symptomatic relief of chronic, intractable pain. o Management of pain associated with post-traumatic or post-operative conditions.

Source page: https://510kreport.com/device/K130052
Methodology: https://510kreport.com/methodology