# K052182: Shian Jia Meei Two Channel Digital T.E.N.S.

- Pathway: 510(k) (Traditional)
- Applicant: Shian Jia Meei Enterprise Co., Ltd.
- Decided: Nov 4, 2005 after 86 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: 3 generations back to K912178 (1991). 7 ancestors in all.
27 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990787: TRIO 300, Ito Co., Ltd. (1999) Summary page 1.

## Most influential descendants
- K070299: Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101) (2007), 26 descendants of its own
- K162517: Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 (2017), 25 descendants of its own
- K182203: JKH Stimulator Plus (2019), 7 descendants of its own
- K203574: HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 (2021), 4 descendants of its own
- K191151: JKH Stimulator Plus (2019), 4 descendants of its own

## Indications for use
The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. is intended for symptomatic relief and management of chronic intractable pain.

Source page: https://510kreport.com/device/K052182
Methodology: https://510kreport.com/methodology