# K021359: Digi-Pro Tens Model WL-2203 and WL-2205

- Pathway: 510(k) (Traditional)
- Applicant: Well-Life Healthcare, Inc.
- Decided: Apr 30, 2002 after 90 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.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K032720: Gem-Stim Tens, Models GM3XY and GM3AXY (2003), 4 descendants of its own
- K042559: Gem-Twin Tens/ Models GM3XY/Z (2004), 2 descendants of its own
- K030537: Digi-Pro Tens/WL-2203B,2204B,2204B-P1,2204B-P2,2205B (2003), 2 descendants of its own
- K033857: T-Tech Digital, Model WL-22XXA Series (2003), 1 descendant of its own
- K122948: Gem-Stim Combo Stimulator (2012), 0 descendants of its own

## Indications for use
This device is a prescription device and only for symptomatic relief of chronic intractable pain. Relaxation of muscle spasms. Prevention or retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Maintaining or increasing range of motion.

Source page: https://510kreport.com/device/K021359
Methodology: https://510kreport.com/methodology