ManaFlexx 2 (model: MF002-RX, MF002-OTC)— 510(k) K231569

Substantially Equivalent

Manamed, Inc.

FDA 510(k) clearance K231569 for ManaFlexx 2 (model: MF002-RX, MF002-OTC), Substantially Equivalent on 2023-11-03. Applicant: Manamed, Inc..

Clearance details

Applicant: Manamed, Inc.
Product code: Code NUH
Advisory panel: Neurology
Date received: 2023-05-31
Decision date: 2023-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

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