# K982388: Surgi Stim

- Pathway: 510(k) (Traditional)
- Applicant: Vision Quest Industries, Inc.
- Decided: Sep 14, 1998 after 67 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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.

## Most influential descendants
- K030507: T.E.a.R. TECH3 Model #44TT03 (2003), 3 descendants of its own
- K090532: T.E.a.R. TECH3 (2009), 2 descendants of its own
- K183692: Avid IF2 (2019), 1 descendant of its own
- K202490: Avid CT2 (2020), 0 descendants of its own

## Indications for use
This device is a ‘combination’ device and has the same indications for use as two different types of predicate devices. High Volt Pulsed Galvanic Stimulators and Neuromuscular Electrical Stimulators share the same indications for use as listed below. Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Maintaining or increasing range of motion Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis Interferential Stimulators have one additional indication for use: Symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post traumatic and post-surgical pain relief.

Source page: https://510kreport.com/device/K982388
Methodology: https://510kreport.com/methodology