# K231440: Combo Electrotherapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Roundwhale Technology Co., Ltd.
- Decided: Nov 3, 2023 after 169 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)
- K171978: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10, Shenzhen Dongdixin Technology Co., Ltd. (2017) Summary page 7.

## Indications for use
Model:R-C101W: 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 Model:R-C101A For TENS/IF 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 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 Model:R-C101B For TENS/IF 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 preventvenous thrombosis Model:R-C101E For IF mode 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain For 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 preventvenous thrombosis Model:R-C101H For TENS and IF mode 1) Symptomatic relief of chronic intractable pain. 2) Post traumatic pain. 3) Post surgical pain. Model:R-C101D For TENS mode 1. Symptomatic relief of chronic intractable pain 2. Post traumatic pain 3. Post surgical pain Model:R-C101G 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 preventvenous thrombosis

Source page: https://510kreport.com/device/K231440
Methodology: https://510kreport.com/methodology