Shenzhen Kentro Medical Electronics Co., Ltd.
FDA Regulatory Profile
Shenzhen Kentro Medical Electronics Co., Ltd. has 0 FDA recalls, 1 inspection, 10 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Aug 15, 2025 · NAI
- Latest 510(k)
- Nov 5, 2024
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 10 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3013671142 | Shenzhen, China | 1 | Aug 15, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242332 | Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401… | Nov 5, 2024 |
| K232517 | Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402… | Dec 8, 2023 |
| K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029… | May 10, 2023 |
| K220998 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 | Aug 24, 2022 |
| K200177 | Low-frequency Multi-function physiotherapy instrument | Mar 25, 2021 |
| K200237 | Transcutaneous Electronic Nerve Stimulator | Oct 19, 2020 |
| K191982 | Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210… | Sep 25, 2020 |
| K183288 | Transcutaneous Electrical Nerve Stimulator | Jul 30, 2019 |
| K181728 | Muscle Trainer | Oct 17, 2018 |
| K170205 | Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 | May 11, 2017 |