# K093138: MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dongdixin Technology Co., Ltd.
- Decided: Feb 12, 2010 after 130 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K984142 (1999). 3 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071137: Sonicator Plus 940, Model ME940, Mettler Electronics Corp. (2007) Summary page 2.

## Most influential descendants
- K113010: FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator (2012), 8 descendants of its own
- K181688: R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator (2018), 6 descendants of its own
- K210021: Axon Therapy (2021), 5 descendants of its own
- K230014: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption (2023), 3 descendants of its own
- K171978: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 (2017), 2 descendants of its own

## Recalls of this device
- Nov 3, 2023 · Class II · Z-0506-2024: The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.

## Indications for use
MT9000 Combo TENS/EMS/IF/MIC Stimulator For TENS 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 For IF mode 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain For MIC mode 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain MT9001 TENS Stimulator 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain MT9002 EMS Stimulator 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 MT9003 IF Stimulator 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post Surgical pain MT9004 MICROCURRENT Stimulator 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post Surgical pain

Source page: https://510kreport.com/device/K093138
Methodology: https://510kreport.com/methodology