# K102014: Tens Stimulator, Models 2800 and 3000

- Pathway: 510(k) (Traditional)
- Applicant: Koalaty Products, Inc.
- Decided: Aug 31, 2010 after 46 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: 5 generations back to K010782 (2001). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100117: LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator, Shenzhen Dongdixin Technology Co., Ltd. (2010) Summary page 2.

## Most influential descendants
- K133779: CP Relief Wand (2014), 1 descendant of its own
- K252236: CP Relief Wand Rx - TENS/NMES (2025), 0 descendants of its own
- K113544: Electronic Pulse Massager Tens Electronic Pulse Massager (2012), 0 descendants of its own

## Indications for use
Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain

Source page: https://510kreport.com/device/K102014
Methodology: https://510kreport.com/methodology