Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ManaSport

K-Number: K210284 · 2022-04-26

ApplicantManamed, Inc.
Decision Date2022-04-26
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ManaSport is the device name listed in this FDA 510(k) record. The listed applicant is Manamed, Inc.. It received FDA 510(k) clearance on 2022-04-26 under 510(k) number K210284. 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 2022-04-26. The listed applicant is Manamed, Inc.. The 510(k) number is K210284.

When did ManaSport receive FDA 510(k) clearance?

ManaSport received FDA 510(k) clearance on 2022-04-26, under 510(k) number K210284.

Who is the listed applicant for ManaSport?

The FDA 510(k) record lists Manamed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ManaSport?

The FDA product code for ManaSport is IMI.

Other records listing Manamed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260944ManaCold Compression SystemK251446PlasmaFlow X Compression Sleeve Device (XPF0001)K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)K222098ManaSport+K211253PlasmaWaveK200353ManaFlow

View all 9 devices →

Related Devices (Code: IMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd.K161628JAS Pulse(TM) Ultrasonic TherapyBonutti Research, 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.

↑