# K980346: Electrical Muscle Stimulator Device ( PGS-4000)

- Pathway: 510(k) (Traditional)
- Applicant: Universal Technology Systems, Inc.
- Decided: Apr 28, 1998 after 90 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
1.Relaxation of muscle spasms; 2.prevention or retardation of disuse atrophy; 3.increasing local blood circulation; 4.muscle re-education; 5.immediate postsurgical stimulation of calf muscles to prevent venous thrombosis; and 6.Maintaining or increasing range of motion.

Source page: https://510kreport.com/device/K980346
Methodology: https://510kreport.com/methodology