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FDA 510(k)

ManaSport+

K-Number: K222098 · 2023-03-08

ApplicantManamed, Inc.
Decision Date2023-03-08
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ManaSport+ is a medical device manufactured by Manamed, Inc.. It received FDA 510(k) clearance on 2023-03-08 under approval number K222098. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ManaSport+?

ManaSport+ is a medical device that received FDA 510(k) clearance on 2023-03-08. It is manufactured by Manamed, Inc.. The 510(k) number is K222098.

When was ManaSport+ approved by the FDA?

ManaSport+ received FDA 510(k) clearance on 2023-03-08, under approval number K222098.

What company makes ManaSport+?

ManaSport+ is manufactured by Manamed, Inc..

What is the FDA product code for ManaSport+?

The FDA product code for ManaSport+ is IMI.

Other Devices by Manamed, Inc.

K160318PlasmaFlow K200353ManaFlow K200351PlasmaFlight K211253PlasmaWave K210284ManaSport K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)

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Related Devices (Code: IMI)

K161628JAS Pulse(TM) Ultrasonic TherapyBonutti Research, Inc. K160075Accent XLAlma Lasers, Inc. K161502MC1 PlusGeneral Project S.R.L. K160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd. K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E Orto K210284ManaSportManamed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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