# K020437: Classic Tens

- Pathway: 510(k) (Traditional)
- Applicant: Care Rehab, Inc.
- Decided: Mar 15, 2002 after 35 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 K895473 (1989). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895473: DSX (TM), Digital SX, Quantum DSX, Model 4700S, Medical Devices, Inc. (1989) Summary page 1.

## Most influential descendants
- K041520: Mantra Tens Model NT3 (2004), 1 descendant of its own
- K091236: Mantra Combo, Model Mecs 320 (2009), 0 descendants of its own
- K041092: Fast Start Tens, Model FS 3001 (2004), 0 descendants of its own

## Indications for use
TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

Source page: https://510kreport.com/device/K020437
Methodology: https://510kreport.com/methodology