Data / Medical devices / China / Shenzhen Jiantuo Electronics Co., Ltd
Shenzhen Jiantuo Electronics Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 4 510(k) clearances
Shenzhen Jiantuo Electronics Co., Ltd is registered with the FDA (registration 3038195193) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 31, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3038195193
- Address
- 608, Block A, Zhuoyue Yulong Haoxuan, Xinyang Community, Shajing Street, Bao'an District, Shenzhen Guangdong, China, 518104
- Owner or operator
- Shenzhen Jiantuo Electronics Co., Ltd (10093000)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- March 15, 2025
- Registered through
- 2027
- Brand names listed
- ENS and Muscle Stimulator (IonMedX; VitaMed), Easy@Home TENS AND MUSCLE STIMULATOR (EHE029N), Electric massager, Electro Therapy Massager MV950, Foot massager, Self-adhesive Electrode Pads, TENS AND EMS (PRO 1200), TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034, AS1080, AS2080) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| December 31, 2025 | K253305 | TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) | NUH | Substantially Equivalent | Shenzhen Jiantuo Electronics Co., Ltd. | accessdata.fda.gov |
| May 11, 2025 | K250360 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) | NUH | Substantially Equivalent | Shenzhen Jiantuo Electronics Co., Ltd. | accessdata.fda.gov |
| May 9, 2025 | K250053 | TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | NUH | Substantially Equivalent | Shenzhen Jiantuo Electronics Co., Ltd. | accessdata.fda.gov |
| August 7, 2018 | K181234 | Self-adhesive Electrode | GXY | Substantially Equivalent | Dong Guan OU Kang Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Electrode, Cutaneous
Updated December 31, 2025. 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.