Identifiers
- 510(k) Number
- K201354 FDA 510(k)
- FDA Product Code
- NGX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5850 FDA 510(k)
- Regulation Number
- 890.5850 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Tens & Pms is a device that provides transcutaneous electrical nerve stimulation (Tens) and pain management stimulation (Pms). It is classified under the product code NGX. The device is used for physical medicine applications. It is a type of electrical stimulator.
The device is supplied by Hong Qiangxing (Shenzhen) Electronics Limited and has received FDA 510K authorization. The device has a clearance type of Traditional and is substantially equivalent. It is available with a specific k number, K201354.
Frequently asked questions
What is the Tens & Pms device used for?
The Tens & Pms device is used for physical medicine applications, providing transcutaneous electrical nerve stimulation and pain management stimulation.
Is the Tens & Pms device supplied sterile?
The device data does not specify if the Tens & Pms device is supplied sterile, it is recommended to consult the manufacturer or device labeling for this information.
What type of authorization has the Tens & Pms device received?
The Tens & Pms device has received FDA 510K authorization, with a clearance type of Traditional and is substantially equivalent, with a specific k number, K201354.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201354 | Class II | Active |
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Manufacturer
- Manufacturer
- Hong Qiangxing (Shenzhen) Electronics Limited
Sources (1)
- FDA 510(k) K201354 24 fields · synced Oct 6, 2026