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FDA 510(k)

BALANCE REHABILITATION UNIT (BRU)

K-Number: K070085 · 2007-02-26

ApplicantMedicaa (Uruguay) S.A.
Decision Date2007-02-26
Product CodeLXV
DecisionSubstantially Equivalent

Device Summary

BALANCE REHABILITATION UNIT (BRU) is the device name listed in this FDA 510(k) record. The listed applicant is Medicaa (Uruguay) S.A.. It received FDA 510(k) clearance on 2007-02-26 under 510(k) number K070085. The device is classified under product code LXV. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BALANCE REHABILITATION UNIT (BRU)?

BALANCE REHABILITATION UNIT (BRU) is a medical device that received FDA 510(k) clearance on 2007-02-26. The listed applicant is Medicaa (Uruguay) S.A.. The 510(k) number is K070085.

When did BALANCE REHABILITATION UNIT (BRU) receive FDA 510(k) clearance?

BALANCE REHABILITATION UNIT (BRU) received FDA 510(k) clearance on 2007-02-26, under 510(k) number K070085.

Who is the listed applicant for BALANCE REHABILITATION UNIT (BRU)?

The FDA 510(k) record lists Medicaa (Uruguay) S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BALANCE REHABILITATION UNIT (BRU)?

The FDA product code for BALANCE REHABILITATION UNIT (BRU) is LXV.

Related Clinical Trials

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Related Devices (Code: LXV)

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.

K220231GyroStimUltrathera Technologies, Inc.K200529OrionInteracoustics A/SK192652TRVInteracoustics A/SK183661ClearEdge Balance SystemQuadrant BiosciencesK190735EQ BalanceUpright Science, Inc.K173669K-D BalanceKing-Devick Technologies, 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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