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FDA 510(k)

BALANCEBACK VNG SYSTEM

K-Number: K042529 · 2004-10-06

ApplicantFall Prevention Technologies, LLC
Decision Date2004-10-06
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BALANCEBACK VNG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fall Prevention Technologies, LLC. It received FDA 510(k) clearance on 2004-10-06 under 510(k) number K042529. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BALANCEBACK VNG SYSTEM?

BALANCEBACK VNG SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-06. The listed applicant is Fall Prevention Technologies, LLC. The 510(k) number is K042529.

When did BALANCEBACK VNG SYSTEM receive FDA 510(k) clearance?

BALANCEBACK VNG SYSTEM received FDA 510(k) clearance on 2004-10-06, under 510(k) number K042529.

Who is the listed applicant for BALANCEBACK VNG SYSTEM?

The FDA 510(k) record lists Fall Prevention Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BALANCEBACK VNG SYSTEM?

The FDA product code for BALANCEBACK VNG SYSTEM is GWN.

Related Clinical Trials

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.

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Other records listing Fall Prevention Technologies, LLC 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.

K070729BALANCEBACK MOBILE INTUITIVE VNG SYSTEM

Related Devices (Code: GWN)

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.

K260566SMARTVERTIGO™ Vestibular Assessment SystemVertigoDx, Inc.K243709NeuroEars-Anna™Neuroears, Inc.K242198ICS Dizcovery (1091)Natus Medical Denmark ApsK242726Synapsys VHITInventis S.R.L.K223047NeuroSwift ProNeurobit Technologies Co., Ltd.K203082Insight Infrared Video GogglesVestibular First

Official Source

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

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