# K100117: LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dongdixin Technology Co., Ltd.
- Decided: Jan 29, 2010 after 14 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010782 (2001). 6 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K082514: Tens/Ems Combo, Ems, Tens, Medihightec Medical Co., Ltd. (2008) Summary page 2.

## Most influential descendants
- K102014: Tens Stimulator, Models 2800 and 3000 (2010), 3 descendants of its own
- 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
LT3000 Combo Stimulator 1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain 2. Increase of blood flow in the treatment area 3. Relaxation of muscle spasm 4. Immediate post-surgical stimulation of muscles to prevent venous thrombosis 5. Prevention or retardation of disuse atrophy 6. Muscle re-education 7. Maintaining or increasing range of motion. LT3001 TENS Stimulator Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain LT3002 EMS Stimulator 1. Relaxation of muscle spasm. 2. Increase of blood flow in the treatment area 3. Immediate post-surgical stimulation of muscles to prevent venous thrombosis 4. Muscle re-education 5. Prevention or retardation of disuse atrophy 6. Maintaining or increasing range of motion.

Source page: https://510kreport.com/device/K100117
Methodology: https://510kreport.com/methodology