# K912178: Bio Tens 601, 606 and 608 (3000)

- Pathway: 510(k) (Traditional)
- Applicant: Skylark Device Co., Ltd.
- Decided: Oct 25, 1991 after 162 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.
89 later devices descend from it; 2 cite it directly.
0 of 90 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
- K972244: NT2000 (1998), 80 descendants of its own
- K990787: TRIO 300 (1999), 78 descendants of its own
- K023231: Elfcare Device, Models 314A Through 314G (2003), 63 descendants of its own
- K063715: Juniper Cooling Device Xtra (2007), 35 descendants of its own
- K072152: Juniper CLN1 Dermal Cooling Device (2007), 34 descendants of its own

Source page: https://510kreport.com/device/K912178
Methodology: https://510kreport.com/methodology