Slendertone Flex Max, Model 517 US
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100556 FDA 510(k)
- FDA Product Code
- NGX 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 Slendertone Flex Max, Model 517 US, is a Powered Muscle Stimulator (21 CFR 890.5850) designed for neuromuscular electrical stimulation (NMES). It delivers controlled electrical impulses to engage and condition abdominal muscles, aiding in targeted muscle training and rehabilitation.
This two-channel, battery-operated system consists of an electronic stimulator module paired with an abdominal electrode belt featuring skin-contact electrodes. Supplied as a reusable device, it operates under FDA 510(k) clearance (K100556) and is intended for use in clinical or home settings. No MRI safety or sterility requirements are specified.
Frequently asked questions
What types of muscle training or rehabilitation can the Slendertone Flex Max, Model 517 US, specifically target, and how does it achieve this?
The Slendertone Flex Max, Model 517 US, is designed for neuromuscular electrical stimulation (NMES) of abdominal muscles. It delivers controlled electrical impulses through an abdominal electrode belt to engage and condition these muscles, making it suitable for targeted muscle training or rehabilitation in clinical or home settings. The two-channel battery-operated system ensures precise stimulation for muscle engagement.
Is the Slendertone Flex Max, Model 517 US, intended for single-use or reusable applications, and what does this mean for maintenance?
The device is explicitly described as reusable, meaning it is not designed for single-use disposal. This implies that users will need to follow manufacturer guidelines for cleaning and maintenance to ensure proper function and hygiene over repeated uses. No sterility requirements are specified, so standard disinfection protocols for reusable medical devices should apply.
How is the Slendertone Flex Max, Model 517 US, powered, and what does this mean for portability and convenience?
The device is battery-operated, which enhances its portability and makes it suitable for use in both clinical and home settings. This design allows for easy transport without the need for a direct power outlet, providing flexibility for patients or clinicians during rehabilitation or training sessions.
What regulatory pathway was followed for the FDA clearance of the Slendertone Flex Max, Model 517 US, and what does this indicate about its intended use?
The device received FDA 510(k) clearance (K100556) under the Traditional 510(k) pathway, with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness). This classification indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, confirming its compliance with FDA standards for neuromuscular electrical stimulation (NMES) devices under 21 CFR 890.5850. The clearance was reviewed by the Physical Medicine (PM) Advisory Committee and filed under product code NGX.
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: SLENDERTONE FLEX MAX, MODEL 517 US - Innolitics, PDF 7AUG02 L. 7 - Food and Drug Administration, SLENDERTONE FLEX MAX, MODEL 517 US 510(k) K100556 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100556 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Medical Research, Ltd.
Sources (1)
- FDA 510(k) K100556 24 fields · synced Oct 6, 2026