# K183074: TENS and EMS Stimulator, TENS Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Astek Technology, Ltd.
- Decided: Jan 11, 2020 after 432 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 K984142 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113010: FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator, Famidoc Technology Co., Ltd. (2012) Summary page 4.

## Indications for use
TENS Stimulator (Model no.: AK-10M) TENS Stimulator provides 5 types TENS output modes (P1-P5) For TENS mode (1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain TENS and EMS Stimulator (Model no.: AK3-20 and AK3-25) TENS and EMS Stimulator provides 8 types output modes (P1-P8). TENS/EMS output modes (P1-P6&P8) and TENS output modes (P7) 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 TENS and EMS Stimulator (Model no.: AK3-50) TENS and EMS Stimulator provides 10 types output modes (P0-P9). TENS output modes (P0-P4) and EMS output modes (P5-P9) 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

Source page: https://510kreport.com/device/K183074
Methodology: https://510kreport.com/methodology