# K032055: Meds-4-Inf+

- Pathway: 510(k) (Traditional)
- Applicant: Medical Equipment Device Specialists
- Decided: Oct 3, 2003 after 93 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- 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 INDICATIONS FOR USE OF THIS DEVICE FOR WHICH A DETERMINATION OF SUBSTANTIAL EQUIVALENCE IS SOUGHT ARE AS FOLLOWS: AS A POWERED MUSCLE STIMULATOR 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis 6. Maintaining or increasing range of motion AS A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR 1. SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN AS AN INTERFERENTIAL CURRENT STIMULATOR 1. SYMPTOMATIC RELIEF OF CHRONIC INTRACTABLE PAIN 2. SYMPTOMATIC RELIEF OF ACUTE PAIN

Source page: https://510kreport.com/device/K032055
Methodology: https://510kreport.com/methodology