Shenzhen Kentro Medical Electronics Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 6 device types, 11 products catalogued, 10 clearances.
Shenzhen Kentro Medical Electronics Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Electrode, Cutaneous, Stimulator, Muscle, Powered and 4 other device types. 11 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
6device types registered with the FDA
11products catalogued under its own name
10510(k) clearances
Registration
| Registered name | SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013671142 |
| FEI number | 3013671142 |
| DUNS | 544395368 |
| Establishment type | Repacker / relabeller, Manufacturer, Exporter |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 2nd Floor, No. 11, Shanzhuang Road, Xikeng Village |
| Postal code | 518115 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrode, Cutaneous | Class 2 | Cutaneous Electrode, Electrode pads, Electrode pads (RHB2029PAK2, RHB2029PAK20) | 2022 | 47 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | Class 2 | Transcutaneous Electrical Nerve Stimulator (Models: KTR-206, KTR-208, KTR-209), Transcutaneous Electrical Nerve Stimulator (RHB1043 refer to KTR-208), Magic TENS FDA-Approved Pain Relief System for Whole-Body, Menstrual & Arthritis Pain (Prospera PL029A refer to KTR-2402, Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412), Rosi(KTR-2412), Penguin Electronic Pulse TENS EMS (Prospera PL009B reference to KTR-2401) and 6 more | 2019 | 22 |
| Stimulator, Muscle, Powered | Class 2 | Transcutaneous Electrical Nerve Stimulator(Model: KTR-4026, KTR-4021, KTR- 4034, KTR-4036, KTR-4037, KTR-4039), Transcutaneous Electrical Nerve Stimulator(Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027), Sunnyload Transcutaneous Electrical Nerve Stimulator(Model: KTR-4015), Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | 2022 | 33 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Transcutaneous Electrical Nerve Stimulator (Model: KTR-2240, KTR-2250, KTR-2241, KTR-2251, KTR-2242, KTR-2252), Transcutaneous Electrical Nerve Stimulator ( Model:KTR-2612, KTR-2642, KTR-2652), Transcutaneous Electrical Nerve Stimulator ( Model:KTR-2610, KTR- 2640, KTR-2650, KTR-2611, KTR-2641, KTR-2651), Transcutaneous Electrical Nerve Stimulator (RHB3004 reference to KTR-2610), Smart-Wave(KTR-2610), Transcutaneous Electrical Nerve Stimulator (Boston Tech ME91 reference to KTR-2610) and 10 more | 2018 | 66 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | Transcutaneous Electrical Nerve Stimulator(Model: KTR-4026, KTR-4021, KTR- 4034, KTR-4036, KTR-4037, KTR-4039), Transcutaneous Electrical Nerve Stimulator(Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027), Sunnyload Transcutaneous Electrical Nerve Stimulator(Model: KTR-4015), Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | 2022 | 32 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | Transcutaneous Electrical Nerve Stimulator (Models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302), Transcutaneous Electrical Nerve Stimulator (Models: KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494), Transcutaneous Electrical Nerve Stimulator (RHB2029 reference to KTR-2493), Smart Stim Transcutaneous Electrical Joint Stimulation Device, ART Transcutaneous Electrical Joint Stimulation Device, Hammacher Schlemmer (KTR-2493) and 27 more | 2017 | 57 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulators | NUH | 36 |
| Transcutaneous Electrical Nerve Stimulator | NUH | 15 |
| kentro | NUH | 12 |
| Powered Muscle Stimulator | NGX | 7 |
| Transcutaneous Electrical Nerve Stimulator For Pain Relief | NUH | 5 |
| Low-Frequency Therapy Instrument | NUH | 4 |
| Dr frankly | NUH | 2 |
| Transcutaneous Electrical Nerve Stimulators | NGX | 2 |
| Transcutaneous Electrical Nerve Stimulator | NGX | 1 |
| smart stim | NUH | 1 |
| vastland | NUH | 1 |
Clearances
10 clearances name Shenzhen Kentro Medical Electronics Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242332 | 2024-11-05 | NUH | Traditional | This company |
| K232517 | 2023-12-08 | NUH | Traditional | This company |
| K222870 | 2023-05-10 | NUH | Traditional | This company |
| K220998 | 2022-08-24 | NUH | Traditional | This company |
| K200177 | 2021-03-25 | NUH | Traditional | This company |
| K200237 | 2020-10-19 | NUH | Traditional | This company |
| K191982 | 2020-09-25 | NUH | Traditional | This company |
| K183288 | 2019-07-30 | NUH | Traditional | This company |
| K181728 | 2018-10-17 | NGX | Traditional | This company |
| K170205 | 2017-05-11 | NUH | Traditional | This company |
| K221589 | 2023-03-24 | GXY | Traditional | Shenzhen Xingyuanli Technology Co., Ltd. |
| K171381 | 2017-12-13 | GXY | Traditional | Shenzhen Quality Medical Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Main products | Neck massager, Lumbar massager, Foot massager, Low frequency therapy instrument, Pelvic floor muscle trainer |
| Certifications | CE, FDA 510(K), CMDCAS13485 |
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.