Cleared Traditional

K231569 - ManaFlexx 2 (model: MF002-RX

K231569 is an FDA 510(k) clearance for ManaFlexx 2 (model: MF002-RX, manufactured by Manamed, Inc.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K231569 · Manamed, Inc. · Neurology device
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Nov 2023
Decision
156d
Days
Class 2
Risk

K231569 is an FDA 510(k) clearance for the ManaFlexx 2 (model: MF002-RX, MF002-OTC). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Manamed, Inc. (Las Vegas, US). The FDA issued a Cleared decision on November 3, 2023 after a review of 156 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Manamed, Inc. devices

FDA 510(k) Submission Details - K231569

510(k) Number K231569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2023
Decision Date November 03, 2023
Days to Decision 156 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 148d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUH Device Classification - Class 2, Special Controls

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 149
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K231569.
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