# K131675: Bodihealth System

- Pathway: 510(k) (Special)
- Applicant: Eprt Technologies, Inc.
- Decided: Mar 12, 2014 after 278 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
Longest line of descent: 1 generation back to K052836 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052836: Bodihealth System, Usa Laser Therapeutics, Inc. (2007) Summary page 1.

## Indications for use
The EPRT Bodihealth TENS System (Transcutaneous Electrical Nerve Stimulator for Pain Relief) with Silver Wrap is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

Source page: https://510kreport.com/device/K131675
Methodology: https://510kreport.com/methodology