TENS & PMS (Model:SM9089 +3 more)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220152 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
- Models / Variants
- Model:SM9089 FDA 510(k)SM9587 FDA 510(k)SM9592 FDA 510(k)SM9555 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TENS & PMS (Models SM9089, SM9587, SM9592, SM9555) are transcutaneous electrical nerve stimulation (TENS) and peripheral muscle stimulation (PMS) devices. These devices deliver low-voltage electrical currents to the skin for pain management and muscle stimulation, targeting nerve pathways to alleviate discomfort or promote muscle function.
These devices are intended for home or clinical use and are supplied as reusable electronic units. They are classified under product code NUH and have received FDA clearance via a 510(k) submission, determined to be substantially equivalent to a predicate device. No third-party review was involved in the clearance process, and the devices are regulated under the Traditional 510(k) pathway with advisory input from the Neurology (NE) panel.
Frequently asked questions
What are the TENS & PMS (SM9089/SM9587/SM9592/SM9555) devices used for?
These devices are designed for transcutaneous electrical nerve stimulation (TENS) and peripheral muscle stimulation (PMS). TENS targets nerve pathways to alleviate discomfort, while PMS promotes muscle function by delivering low-voltage electrical currents through the skin. They are suitable for both home and clinical settings to manage pain or improve muscle activity.
Are the TENS & PMS devices single-use or reusable?
The TENS & PMS devices (models SM9089, SM9587, SM9592, SM9555) are supplied as reusable electronic units. Unlike disposable devices, they are intended for repeated use, provided they are maintained and operated according to manufacturer guidelines.
What regulatory pathway did these devices follow for FDA clearance?
The TENS & PMS devices received FDA clearance through a Traditional 510(k) submission, determined to be substantially equivalent to a predicate device. The clearance was granted without third-party review and involved advisory input from the Neurology (NE) panel. The decision was made under product code NUH.
How are these devices supplied, and what should be considered for storage?
The devices are supplied as reusable electronic units, meaning they come ready for immediate clinical or home use. Proper storage involves keeping them in a clean, dry environment, away from direct sunlight or extreme temperatures, to ensure optimal performance and longevity. Follow manufacturer instructions for any specific storage recommendations.
Are there different models available, and what distinguishes them?
Yes, there are four models available: SM9089, SM9587, SM9592, and SM9555. While all serve the same primary purpose of TENS and PMS, distinctions between models may lie in specific features like electrode configurations, stimulation patterns, or user interface design. Check the manufacturer’s documentation for detailed differences applicable to your clinical or home use needs.
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 | K220152 | Class II | Active |
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Manufacturer
- Manufacturer
- Hong Qiangxing (Shenzhen) Electronics Limited
Sources (1)
- FDA 510(k) K220152 24 fields · synced Oct 5, 2026