510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K072475Substantially Equivalent

Balder Finesse and Junior Powered Wheelchairs (with Stand-Up Option)

Etac Sverige AB, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072475 is the FDA 510(k) clearance record for BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION), a class II device, cleared for Etac Sverige AB on under FDA product code IPL (Wheelchair, Standup). FDA records list one 510(k) clearance for Etac Sverige AB. As of , FDA records show no recalls naming K072475.

Clearance record

Decision date
Received
(108 days to decision)
Product code
IPL Wheelchair, Standup
Regulation
21 CFR 890.3900
Device class
Class II
Review panel
Physical Medicine
Applicant
Etac Sverige AB 1705. Capital Of Texas Hwy., Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IPL

Trailing 12 months

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

FDA records show no clearances under product code IPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IPL, 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