Identifiers
- 510(k) Number
- K961376 FDA 510(k)
- FDA Product Code
- GZJ 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 Smart-TENS Model 456 is a transcutaneous electrical nerve stimulation (TENS) device, classified under product code GZJ. It delivers electrical impulses through electrodes applied to the skin to manage pain by interfering with pain signal transmission along nerve pathways.
This device is intended for use in clinical and home settings, supplied as a reusable medical instrument. It adheres to safety standards including EN 60601-1 (IEC 601-1) and EN 60601-1-2 (IEC 601-1-2) to mitigate electrical and mechanical hazards. Authorized under FDA 510(k) clearance (K961376), it was reviewed by the Neurology Advisory Committee in 1996 and remains subject to traditional review processes.
Frequently asked questions
What clinical settings is the Smart-TENS Model 456 approved for use in, and how does it differ from typical home use?
The Smart-TENS Model 456 is approved for use in both clinical and home settings. It is designed as a reusable medical instrument, meaning it can be used in professional healthcare environments like hospitals or clinics, as well as by patients at home. The key difference lies in the level of supervision: clinical use involves trained personnel managing the device, while home use is intended for self-administration by patients under guidance from healthcare providers.
How is the Smart-TENS Model 456 different from other TENS devices in terms of safety standards?
The Smart-TENS Model 456 adheres to specific safety standards to ensure electrical and mechanical safety during use. It complies with EN 60601-1 (IEC 601-1) and EN 60601-1-2 (IEC 601-1-2), which are international standards for medical electrical equipment. These standards help mitigate risks like electrical shock, burns, or mechanical failure, distinguishing it from non-medical-grade TENS devices that may not meet these rigorous requirements.
Is the Smart-TENS Model 456 single-use or reusable, and what does that mean for maintenance?
The Smart-TENS Model 456 is designed as a reusable medical instrument, meaning it is intended for repeated use rather than disposal after a single application. This requires proper cleaning, disinfection, and maintenance between uses to ensure hygiene and functionality. Reusability also implies that it must be stored and handled according to clinical protocols to prevent contamination or damage, unlike single-use devices that are discarded after one session.
What was the basis for the FDA’s clearance of the Smart-TENS Model 456, and how was it reviewed?
The Smart-TENS Model 456 received FDA 510(k) clearance (K961376) under a traditional review process, meaning the manufacturer demonstrated that it is substantially equivalent to a legally marketed device already on the market. The device was reviewed by the Neurology Advisory Committee (NE) in 1996, which evaluated its safety and performance before clearance. This classification under product code GZJ reflects its role in pain management through transcutaneous electrical stimulation.
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. Sources consulted: SMART-TENS, MODEL 456 (K961376) — FDA 510 (k) | Innolitics, SMART-TENS, MODEL 456 510(k) K961376 - FDA.report, Smart-tens, Model 456 - Beudamed, PDF K961376 SMART-TENS, MODEL 456 - 510kdatabase.net, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K961376 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Medical Research, Ltd.
Sources (1)
- FDA 510(k) K961376 24 fields · synced Sep 19, 2026