# K202186: TrueRelief Device

- Pathway: 510(k) (Traditional)
- Applicant: Truerelief
- Decided: Mar 23, 2021 after 231 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: 4 generations back to K881114 (1988). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070474: Newlife Sciences LLC, Model TMR, Newlife Sciences, LLC (2007) Summary page 4.
- K153696: Chattanooga Revolution Wireless, Djo, LLC (2016) Summary page 4.

## Indications for use
The TrueRelief Device is intended for use under the supervision of a Healthcare Professional. TrueRelief is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Source page: https://510kreport.com/device/K202186
Methodology: https://510kreport.com/methodology