Shenzhen Kentro Medical Electronics Co., Ltd
Shenzhen Guangdong, CN
SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Shenzhen Kentro Medical Electronics Co., Ltd between 2017 and 2024. The busiest year on record is 2020, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K232517 | Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) | NUH | Substantially Equivalent | |
| 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 | |
| K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | NUH | Substantially Equivalent | |
| K200177 | Low-frequency Multi-function physiotherapy instrument | NUH | Substantially Equivalent | |
| K200237 | Transcutaneous Electronic Nerve Stimulator | NUH | Substantially Equivalent | |
| 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 | |
| K183288 | Transcutaneous Electrical Nerve Stimulator | NUH | Substantially Equivalent | |
| K181728 | Muscle Trainer | NGX | Substantially Equivalent | |
| K170205 | Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 | NUH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013671142 | 3013671142 | SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD | 2nd Floor, No. 11, Shanzhuang Road, Xikeng Village, Shenzhen Guangdong 518115 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain