# K050174: Bio-Stim Kit

- Pathway: 510(k) (Traditional)
- Applicant: Skylark Device & Systems Co., Ltd.
- Decided: Sep 7, 2005 after 225 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.
154 later devices descend from it; 2 cite it directly.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K060846: Therapeutic Massage Companion (2007), 151 descendants of its own
- K102598: HI-Dow-XP (2011), 78 descendants of its own
- K112392: Hivox Biotek Inc. (2012), 58 descendants of its own
- K122744: Prospera Otc Tens Electronic Pulse Massager (2013), 55 descendants of its own
- K110068: Model PM3030 (2011), 50 descendants of its own

## Indications for use
This BIO-STIM KIT is intended for temporary relief of pain associated with sore and aching muscle in the lower back due to strain from exercise or normal household and work activities.

Source page: https://510kreport.com/device/K050174
Methodology: https://510kreport.com/methodology