# K180956: Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Roundwhale Technology Co., Ltd.
- Decided: Jun 7, 2018 after 56 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
Longest line of descent: 1 generation back to K130802 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130802: Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060), Shenzhen Dongdixin Technology Co., Ltd. (2013) Summary page 5.

## Indications for use
R-C1 TENS and EMS Stimulator TENS: This mode is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. R-E1 EMS Stimulator This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. R-T1 TENS Stimulator This device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

Source page: https://510kreport.com/device/K180956
Methodology: https://510kreport.com/methodology