# K181688: R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Roundwhale Technology Co., Ltd.
- Decided: Sep 7, 2018 after 73 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.
6 later devices descend from it; 1 cites it directly.
0 of 12 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 6.

## Most influential descendants
- 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
- K250286: Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) (2025), 0 descendants of its own

## Indications for use
R-C1 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. R-E1 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 calf muscles to prevent venous thrombosis. R-T1 TENS Stimulator 1. Symptomatic relief of chronic intractable pain; 2. Post traumatic pain; 3. Post surgical pain.

Source page: https://510kreport.com/device/K181688
Methodology: https://510kreport.com/methodology