510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K070085Substantially Equivalent

Balance Rehabilitation Unit (Bru)

Medicaa (Uruguay) S.A., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070085 is the FDA 510(k) clearance record for BALANCE REHABILITATION UNIT (BRU), cleared for Medicaa (Uruguay) S.A. on under FDA product code LXV (Apparatus, Vestibular Analysis). FDA records list one 510(k) clearance for Medicaa (Uruguay) S.A. As of , FDA records show no recalls naming K070085.

Clearance record

Decision date
Received
(48 days to decision)
Product code
LXV Apparatus, Vestibular Analysis
Device class
Unclassified
Review panel
Unknown
Applicant
Medicaa (Uruguay) S.A. 1101 S. Capital Texas Hwy., Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LXV

Trailing 12 months

FDA records hold no clearances under product code LXV in the trailing twelve months.

FDA records show no clearances under product code LXV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LXV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260