# Shenzhen Roundwhale Technology Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 7 (2018–2024): 7 510(k) clearances
- Product codes: NUH (3), IPF (2), GXY (2)
- 510(k) review time since 2016: median 111 days, against 121 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 9 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shenzhen Dongdixin Technology Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-dongdixin-technology)
- Famidoc Technology Co., Ltd.: 1 (https://510kreport.com/company/famidoc-technology)
- Zmi Electronics, Ltd.: 1 (https://510kreport.com/company/zmi-electronics)
- Gmdasz Manufacturing Co., Ltd.: 1 (https://510kreport.com/company/gmdasz-manufacturing)
- Biowave Corporation: 1 (https://510kreport.com/company/biowave)
- Media Plus, LLC: 1 (https://510kreport.com/company/media-plus)
- Shenzhen Konmed Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-konmed-technology)

## Firms that cite its devices most
- Neuralace Medical, Inc.: 1 (https://510kreport.com/company/neuralace-medical)
- Mettler Electronics Corp.: 1 (https://510kreport.com/company/mettler-electronics)

## Its most-cited devices
- K181688: R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator (2018), cited by 1
- K222252: Self-adhesive Electrode (2023), cited by 1
- K192087: Combo Electrotherapy Device (2019), cited by 1

## Recent decisions
- K231423: Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) (Jan 22, 2024)
- K232995: Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe (Jan 11, 2024)
- K231440: Combo Electrotherapy Device (Nov 3, 2023)
- K222252: Self-adhesive Electrode (Jan 19, 2023)
- K192087: Combo Electrotherapy Device (Nov 1, 2019)
- K181688: R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator (Sep 7, 2018)
- K180956: Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator (Jun 7, 2018)

Source page: https://510kreport.com/company/shenzhen-roundwhale-technology