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Sys Stim 206 Model ME206

FDA 510(k)

Class II (US FDA 510(k))

510(k) K851735

by Mettler Electronics Corp.

Identifiers

510(k) Number
K851735 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 Sys Stim 206 Model ME206 is a microprocessor-controlled neuromuscular electrical stimulator (NMES) designed to deliver targeted electrical stimulation for neuromuscular rehabilitation. It generates four distinct waveforms—narrow pulse, wide pulse, alternating current (AC), and continuous direct current—with electrically balanced pulsed waveforms featuring zero net charge.

This device is intended for single-use or reusable clinical settings, supplied as a standalone stimulator with no specified sterility requirements. It operates in environments where MRI safety is not a concern, as no data indicates compatibility or restrictions. The device is authorised under FDA 510(k) clearance (K851735) and is regulated as a neuromuscular stimulator under product code GZJ. Storage conditions are not detailed in the specifications.

Frequently asked questions

What types of electrical waveforms does the Sys Stim 206 Model ME206 support for neuromuscular rehabilitation, and how does this differ from other stimulators?

The Sys Stim 206 Model ME206 offers four distinct waveforms—narrow pulse, wide pulse, alternating current (AC), and continuous direct current—with electrically balanced pulsed waveforms that ensure zero net charge. This design helps reduce skin irritation and discomfort compared to stimulators that lack waveform balancing, making it suitable for prolonged or sensitive neuromuscular rehabilitation sessions.

Is the Sys Stim 206 Model ME206 intended for single-use or reusable applications, and what does this mean for clinical workflows?

The device is explicitly designed for both single-use and reusable clinical settings, giving facilities flexibility based on infection control protocols and patient volume. Clinicians can choose to use it once per patient (disposable electrodes) or sterilize and reuse it for multiple sessions (with proper cleaning and maintenance), though no sterility requirements are specified for the device itself.

Can the Sys Stim 206 Model ME206 be used in an MRI environment, and why might this matter for some facilities?

The device cannot be used in MRI environments due to insufficient data on MRI compatibility or safety restrictions. This is critical for facilities where patients may require both neuromuscular stimulation and MRI scans, as improper use near MRI machines could pose risks to patients or damage the equipment.

What regulatory pathway was followed for FDA clearance of the Sys Stim 206 Model ME206, and what does this mean for its use in clinical settings?

The device received FDA clearance via a Traditional 510(k) pathway (K851735) under the Neurology advisory committee (NE) and is classified under product code GZJ (Neuromuscular Stimulator). This means it was deemed *substantially equivalent* to a legally marketed predecessor, ensuring it meets established safety and effectiveness standards for neuromuscular electrical stimulation in clinical rehabilitation.

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: Mettler Electronics SYS-STIM 206 Instruction Manual, Sys*Stim 206 Instruction Manual - Mettler Electronics | Manualzz, Mettler Electronics SYS-STIM 206 Instruction Manual, Mettler electronics SYS-STIM 206 Manuals | ManualsLib

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mettler Electronics Corp.

Sources (1)

  • FDA 510(k) K851735 24 fields · synced Sep 19, 2026