# K021436: Ttech Model 200E + Tens Device

- Pathway: 510(k) (Traditional)
- Applicant: Theratech, Inc.
- Decided: Jul 30, 2002 after 85 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 K002874 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K002874: Well-Tens, Well-Life Consultant (2001) Summary page 1.

## Most influential descendants
- K073438: Prostim 1000/2000 (2008), 0 descendants of its own

## Indications for use
The Ttech Model 200E + TENS Device is intended for symptomatic relief of chronic intractable pain.

Source page: https://510kreport.com/device/K021436
Methodology: https://510kreport.com/methodology