# K192087: Combo Electrotherapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Roundwhale Technology Co., Ltd.
- Decided: Nov 1, 2019 after 88 days
- Product code: NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K231423: Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) (2024), 0 descendants of its own

## Indications for use
Over-The-Counter Use: TENS mode:: It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. EMS mode: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. Prescription Use: 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.

Source page: https://510kreport.com/device/K192087
Methodology: https://510kreport.com/methodology