# K171978: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dongdixin Technology Co., Ltd.
- Decided: Oct 2, 2017 after 94 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: 3 generations back to K984142 (1999). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093138: MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003, Shenzhen Dongdixin Technology Co., Ltd. (2010) Summary page 6.
- K071137: Sonicator Plus 940, Model ME940, Mettler Electronics Corp. (2007) Summary page 6.

## Most influential descendants
- K231440: Combo Electrotherapy Device (2023), 0 descendants of its own
- K213197: MyOnyx System (2022), 0 descendants of its own

## Indications for use
Combo Stimulator MT9000 For TENS/IF/MIC mode 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain For EMS mode 1. Relaxation of muscle spasm. 2. Increase of local blood flow circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis Combo Stimulator LT7102 For TENS/IF/MIC mode 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain For EMS/RUSS mode 1. Relaxation of muscle spasm. 2. Increase of local blood flow circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis TENS Stimulator InTENSity 10 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain

Source page: https://510kreport.com/device/K171978
Methodology: https://510kreport.com/methodology