# K113010: FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Famidoc Technology Co., Ltd.
- Decided: Dec 21, 2012 after 437 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.
8 later devices descend from it; 2 cite it directly.
0 of 13 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 2.

## Most influential descendants
- 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
- K233364: Axon Therapy (2024), 1 descendant of its own
- K250309: BTL-199 (2025), 0 descendants of its own

## Indications for use
FDESIOI(ED4OI) TENS and EMS 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 calf muscles to prevent venous thrombosis FDESIO2(ED402) TENS Stimulator 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain FDESIO3(ED403) EMS Stimulator 1. Relaxation of muscle spasm. 2. Increase of 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 calf muscles to prevent venous thrombosis

Source page: https://510kreport.com/device/K113010
Methodology: https://510kreport.com/methodology