# K212618: iRelieve Microcurrent Pain Relief System

- Pathway: 510(k) (Traditional)
- Applicant: Fast Track Technologies, Inc.
- Decided: Sep 14, 2022 after 392 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 K912178 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013167: MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500, Newcare Products, LLC (2002) Summary page 4.

## Indications for use
The iRelieve Microcurrent Pain Relief System is intended to be used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain.

Source page: https://510kreport.com/device/K212618
Methodology: https://510kreport.com/methodology