ManaFlexx 2 (model: MF002-RX, MF002-OTC)

FDA 510(k) K231569 · Manamed, Inc.

Substantially Equivalent

510(k) numberK231569

Submission

Device name
ManaFlexx 2 (model: MF002-RX, MF002-OTC)
Applicant
Manamed, Inc.
Las Vegas, NV, US
Received
May 31, 2023
Decision date
November 3, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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Questions and answers

When was ManaFlexx 2 (model: MF002-RX, MF002-OTC) cleared by the FDA?

ManaFlexx 2 (model: MF002-RX, MF002-OTC) (K231569) received a 510(k) decision of Substantially Equivalent on November 3, 2023, 156 days after the submission was received.

What is the product code of K231569?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.