Data / Medical devices / China / Shenzhen Kentro Medical Electronics Co., Ltd
Shenzhen Kentro Medical Electronics Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 12 510(k) clearances
Shenzhen Kentro Medical Electronics Co., Ltd is registered with the FDA (registration 3013671142) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 12 510(k) clearances under its listings, the newest dated November 5, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013671142
- Address
- 2nd Floor, No. 11, Shanzhuang Road, Xikeng Village Yuanshan Street, Longgang District, Shenzhen Guangdong, China, 518115
- Owner or operator
- SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD (10055119)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- June 9, 2017
- Registered through
- 2026
- Brand names listed
- ART Transcutaneous Electrical Joint Stimulation Device, Cutaneous Electrode, Electrode pads, Electrode pads (RHB2029PAK2, RHB2029PAK20), Hammacher Schlemmer (KTR-2493), KTR-201, KTR-202, KTR-203 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | 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 | 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 |
|---|---|---|---|---|---|---|
| November 5, 2024 | K242332 | Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494) | NUH | Substantially Equivalent | Shenzhen Kentro Medical Electronics Co., Ltd. | accessdata.fda.gov |
| December 8, 2023 | K232517 | Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) | NUH | Substantially Equivalent | Shenzhen Kentro Medical Electronics Co., Ltd. | accessdata.fda.gov |
| May 10, 2023 | K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 | NUH | Substantially Equivalent | Shenzhen Kentro Medical Electronics Co., Ltd. | accessdata.fda.gov |
| March 24, 2023 | K221589 | Starly pad | GXY | Substantially Equivalent | Shenzhen Xingyuanli Technology Co., Ltd. | accessdata.fda.gov |
| August 24, 2022 | K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | NUH | Substantially Equivalent | Shenzhen Kentro Medical Electronics Co., Ltd. | accessdata.fda.gov |
| March 25, 2021 | K200177 | Low-frequency Multi-function physiotherapy instrument | NUH | Substantially Equivalent | Shenzhen Kentro Medical Electronics Co., Ltd. | accessdata.fda.gov |
| October 19, 2020 | K200237 | Transcutaneous Electronic Nerve Stimulator | NUH | Substantially Equivalent | Shenzhen Kentro Medical Electronics Co., Ltd. | accessdata.fda.gov |
| September 25, 2020 | K191982 | Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) | NUH | Substantially Equivalent | Shenzhen Kentro Medical Electronics Co., Ltd. | accessdata.fda.gov |
| July 30, 2019 | K183288 | Transcutaneous Electrical Nerve Stimulator | NUH | Substantially Equivalent | Shenzhen Kentro Medical Electronics Co., Ltd. | accessdata.fda.gov |
| October 17, 2018 | K181728 | Muscle Trainer | NGX | Substantially Equivalent | Shenzhen Kentro Medical Electronics Co., Ltd. | accessdata.fda.gov |
| December 13, 2017 | K171381 | Adhesive Electrodes | GXY | Substantially Equivalent | Shenzhen Quality Medical Technology Co.,Ltd | accessdata.fda.gov |
| May 11, 2017 | K170205 | Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 | NUH | Substantially Equivalent | Shenzhen Kentro Medical Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Electrical, Transcutaneous, For Arthritis
- All makers of Electrode, Cutaneous
Updated November 5, 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.