# K011588: Suretone

- Pathway: 510(k) (Traditional)
- Applicant: Suretone International
- Decided: Mar 28, 2002 after 309 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
The “Surestim” is an electrical powered muscle stimulator used to apply an electrical current through electrodes to a patient’s skin for the relaxation of muscle spasms.

Source page: https://510kreport.com/device/K011588
Methodology: https://510kreport.com/methodology