# K052836: Bodihealth System

- Pathway: 510(k) (Traditional)
- Applicant: Usa Laser Therapeutics, Inc.
- Decided: Feb 13, 2007 after 495 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K131675: Bodihealth System (2014), 0 descendants of its own
- K121578: Atom 1 (Model: BRC 2200) (2012), 0 descendants of its own

## Indications for use
The BodiHealth System 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/K052836
Methodology: https://510kreport.com/methodology