# K970429: Bioscope SD Tens, Arista SD Plus, AP-102080T

- Pathway: 510(k) (Traditional)
- Applicant: Apex Medical Corp.
- Decided: Apr 29, 1997 after 84 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.
2 later devices descend from it; 2 cite 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K071624: Everelife Transcutaneous Muscle Stimulator (2007), 0 descendants of its own
- K061828: Lorenz Biotech Aptiva, Version 2.13 (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K970429
Methodology: https://510kreport.com/methodology