Data / Medical devices / China / Shenzhen Roundwhale Technology Co. Ltd.
Shenzhen Roundwhale Technology Co. Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 7 510(k) clearances
Shenzhen Roundwhale Technology Co. Ltd. is registered with the FDA (registration 3014314933) in Shenzhen Guangdong, China. It lists 8 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 22, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014314933
- Address
- 202,2/F, Building 27, Dafa Industrial Park, Longxi Community Longgang Street, Longgang District, Shenzhen Guangdong, China, 518116
- Owner or operator
- Shenzhen Roundwhale Technology Co. Ltd. (10057039)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 13, 2018
- Registered through
- 2026
- Brand names listed
- AHC-T7K, Archer Dual Stim Pro, BRVE2, Combo Electrotherapy Device (M101A-UK1), Combo Electrotherapy Device (Magic), Combo Electrotherapy Device (R-C101J),AE177, Combo Electrotherapy Device (Model: R-C101C, R-C101D, R-C101F, R-C101G,F100, MINI TENS COMB,R-C101I,TENS3500,R-C101K), Combo Electrotherapy Device(Model:R-C10IW,R-C101A,R-C101B,R-C101E,R-C101H,R-C101D,R-C101G), Combo-T, Combo-TS, SavvyStim and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Interferential Current Therapy | LIH | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 22, 2024 | K231423 | Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) | NUH | Substantially Equivalent | Shenzhen Roundwhale Technology Co. , Ltd. | accessdata.fda.gov |
| January 11, 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 | GXY | Substantially Equivalent | Shenzhen Roundwhale Technology Co. , Ltd. | accessdata.fda.gov |
| November 3, 2023 | K231440 | Combo Electrotherapy Device | IPF | Substantially Equivalent | Shenzhen Roundwhale Technology Co. , Ltd. | accessdata.fda.gov |
| January 19, 2023 | K222252 | Self-adhesive Electrode | GXY | Substantially Equivalent | Shenzhen Roundwhale Technology Co. , Ltd. | accessdata.fda.gov |
| November 1, 2019 | K192087 | Combo Electrotherapy Device | NUH | Substantially Equivalent | Shenzhen Roundwhale Technology Co. , Ltd. | accessdata.fda.gov |
| September 7, 2018 | K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | IPF | Substantially Equivalent | Shenzhen Roundwhale Technology Co. , Ltd. | accessdata.fda.gov |
| June 7, 2018 | K180956 | Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator | NUH | Substantially Equivalent | Shenzhen Roundwhale Technology Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Interferential Current Therapy
- All makers of Massager, Therapeutic, Electric
Updated January 22, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.