# K051128: Electropulse

- Pathway: 510(k) (Traditional)
- Applicant: Pain Relief Technologies
- Decided: Mar 10, 2006 after 311 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
TENS The symptomatic relief and management of chronic intractable pain, and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain. Vibration Relaxing muscles and relieving minor aches and pains. Heat Lamp Emits energy at infrared frequencies to provide topical heating and to provide temporary relief of minor muscle and joint pain, relieving stiffness, promoting relaxing of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

Source page: https://510kreport.com/device/K051128
Methodology: https://510kreport.com/methodology