Tenzcare Dual-Channel Stimulator
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K800758 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 Tenzcare Dual-Channel Stimulator is a transcutaneous nerve stimulator for pain relief, classified under product code GZJ and regulation 882.5890. It is a device intended for use in neurology applications as a nerve stimulator.
The device received FDA 510(k) clearance (K800758) on April 10, 1980, following a traditional review process. It was submitted by 3M Company and determined to be substantially equivalent to a predicate device. The stimulator is supplied as a reusable or single-use device depending on configuration, though specific sterility, MRI safety, size, storage, and usage settings are not detailed in the provided data.
Frequently asked questions
What is the TENZCARE DUAL-CHANNEL STIMULATOR used for?
The TENZCARE DUAL-CHANNEL STIMULATOR is a transcutaneous nerve stimulator designed for pain relief in neurology applications. It works by delivering electrical stimulation through the skin to help manage nerve-related pain conditions.
Is the TENZCARE DUAL-CHANNEL STIMULATOR reusable or single-use?
The TENZCARE DUAL-CHANNEL STIMULATOR is supplied as either a reusable or single-use device depending on the configuration selected. The specific configuration details would need to be confirmed with the manufacturer based on the intended application.
What regulatory approvals does the TENZCARE DUAL-CHANNEL STIMULATOR have?
The TENZCARE DUAL-CHANNEL STIMULATOR received FDA 510(k) clearance (K800758) on April 10, 1980. It was determined to be substantially equivalent to a predicate device and is classified under product code GZJ and regulation 882.5890.
What are the specifications of the TENZCARE DUAL-CHANNEL STIMULATOR?
The TENZCARE DUAL-CHANNEL STIMULATOR is a dual-channel device designed for transcutaneous nerve stimulation. Specific details regarding sterility, MRI safety, sizes, storage requirements, and usage settings are not provided in the available device data.
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: Tenzcare Dual-channel Stimulator 510 (k) K800758 - FDA.report, K800758 - TENZCARE DUAL-CHANNEL STIMULATOR | FDA 510 (k), Tenzcare Dual-channel Stimulator - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K800758 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K800758 24 fields · synced Sep 26, 2026