Identifiers
- 510(k) Number
- K031017 FDA 510(k)
- FDA Product Code
- IPF 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 SysStim 208 and 208A are two-channel neuromuscular stimulators designed to deliver electrical stimulation for therapeutic purposes. These devices provide controlled electrical impulses to facilitate muscle activation, rehabilitation, or pain management under clinical supervision. They operate via adjustable intensity and frequency settings to tailor stimulation parameters to patient needs. The devices fall under the category of physical medicine devices, as classified by regulatory submissions.
The SysStim 208 and 208A are intended for use in clinical settings such as physical therapy, rehabilitation centers, or pain management facilities. They are supplied as reusable medical devices and include features like a digital timer and a remote patient safety switch for operator and patient control. The stimulators are not classified as single-use and require proper maintenance and storage per manufacturer guidelines. Their regulatory status includes FDA clearance under a 510(k) submission, with a decision date of May 30, 2003.
Frequently asked questions
Are the SysStim 208 and 208A devices meant for home use or strictly clinical settings like physical therapy or rehabilitation centers?
The SysStim 208 and 208A are designed exclusively for clinical use in settings such as physical therapy, rehabilitation centers, or pain management facilities. Their features—like adjustable intensity/frequency controls, a digital timer, and a remote patient safety switch—are tailored for supervised therapeutic applications, not home use.
How are the SysStim 208 and 208A devices supplied, and do they require special handling or maintenance?
These devices are reusable, not single-use, and must be maintained per the manufacturer’s guidelines. They are not sterile out-of-the-box and are intended for repeated use in clinical environments. Proper cleaning and storage are essential to ensure reliability and patient safety.
What regulatory pathway was followed for FDA clearance of the SysStim 208 and 208A, and when was the decision made?
The SysStim 208 and 208A received FDA clearance under a 510(k) submission (traditional review) as substantially equivalent to a predicate device. The decision was made by the Physical Medicine (PM) Advisory Committee on May 30, 2003, with the submission filed on March 31, 2003.
Do the SysStim 208 and 208A include any safety features for both the patient and operator during use?
Yes, the devices incorporate a remote patient safety switch to allow the operator to control stimulation remotely, enhancing safety during therapy. This feature, combined with adjustable intensity/frequency settings, helps tailor treatment while minimizing risks.
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: Sys*Stim 208A « The World Leader in Therapeutic Equipment, METTLER ELECTRONICS 208A Neuromuscular Stimulator Instruction Manual, PDF Sys*Stim 208A - mettlerelectronics.com, PDF METTLER ELECTRONICS 208A Neuromuscular Stimulator ... - Manuals+
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031017 | Class II | Active |
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Manufacturer
- Manufacturer
- Mettler Electronics Corp.
Sources (1)
- FDA 510(k) K031017 24 fields · synced Sep 19, 2026