Shenzhen Roundwhale Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 8 device types, 10 products catalogued, 7 clearances.
Shenzhen Roundwhale Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cable, Electrode, Electrode, Cutaneous and 6 other device types. 10 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
8device types registered with the FDA
10products catalogued under its own name
7510(k) clearances
Registration
| Registered name | SHENZHEN ROUNDWHALE TECHNOLOGY CO. LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014314933 |
| FEI number | 3014314933 |
| DUNS | 544587118 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 202,2/F, Building 27, Dafa Industrial Park, Longxi Community |
| Postal code | 518116 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cable, Electrode | Class 2 | Electrode Cable | 2018 | 47 |
| Electrode, Cutaneous | Class 2 | Neurological Therapy Devices – Accessories (Model:AC3002 AC3004 AC3006 AC3003 AC3005 AC3007), Neurological Therapy Devices – Accessories (Model:AC1001 AC1002 AC1003 AC1004 AC1005), Neurological Therapy Devices – Accessories (Model:AC3001 AC3008 AC3009 AC3010 AC3011), Neurological Therapy Devices – Accessories (Model:AC4001 AC4002 AC4003 AC5001 AC5002 AC5003), Neurological Therapy Devices – Accessories (Model:AC8001 AC9001), Neurological Therapy Devices – Accessories (Model:AC7001 AC7002 AC7003) and 4 more | 2023 | 47 |
| Interferential Current Therapy | Class 2 | Combo Electrotherapy Device(Model:R-C10IW,R-C101A,R-C101B,R-C101E,R-C101H,R-C101D,R-C101G) | 2023 | 7 |
| Massager, Therapeutic, Electric | Class 1 | Massager: R-C1,R-T1,R-E1,R-C3,R-C4A,R-C4B,R-C4C,R-C4D | 2019 | 437 |
| Stimulator, Muscle, Powered | Class 2 | Combo Electrotherapy Device(Model:R-C10IW,R-C101A,R-C101B,R-C101E,R-C101H,R-C101D,R-C101G), Combo Electrotherapy Device (M101A-UK1), ZZACOMBOBDPT2, Istim M2, Zzacombo, R-C101J, and 16 more | 2019 | 33 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Combo Electrotherapy Device (M101A-UK1), ZZACOMBOBDPT2, Istim M2, Zzacombo, R-C101J,, RHB2026GRY and 17 more | 2018 | 66 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | Combo Electrotherapy Device(Model:R-C10IW,R-C101A,R-C101B,R-C101E,R-C101H,R-C101D,R-C101G), Combo Electrotherapy Device (M101A-UK1), ZZACOMBOBDPT2, Istim M2, Zzacombo, R-C101J, and 16 more | 2019 | 32 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | Combo Electrotherapy Device (M101A-UK1), ZZACOMBOBDPT2, Istim M2, Zzacombo, R-C101J,, RHB2026GRY and 17 more | 2018 | 57 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K231423 | 2024-01-22 | NUH | Traditional | This company |
| K232995 | 2024-01-11 | GXY | Traditional | This company |
| K231440 | 2023-11-03 | IPF | Traditional | This company |
| K222252 | 2023-01-19 | GXY | Traditional | This company |
| K192087 | 2019-11-01 | NUH | Traditional | This company |
| K181688 | 2018-09-07 | IPF | Traditional | This company |
| K180956 | 2018-06-07 | NUH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | TENS devices, EMS devices, interferential current, micro-current, massage equipment |
|---|---|
| Certifications | ISO 13485, CE2460, FDA |
| Export markets | European Union, United States |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.