510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223533Substantially Equivalent

Little Wave Arc; Little Wave Flip

Ki Mobility, Stevens Point WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223533 is the FDA 510(k) clearance record for Little Wave Arc; Little Wave Flip, a class I device, cleared for Ki Mobility, LLC on under FDA product code LBE (Stroller, Adaptive). FDA records list 5 510(k) clearances for Ki Mobility, LLC, from to . As of , FDA records show no recalls naming K223533.

Clearance record

Decision date
Received
(281 days to decision)
Product code
LBE Stroller, Adaptive
Regulation
21 CFR 890.3850
Device class
Class I
Review panel
Physical Medicine
Applicant
Ki Mobility, LLC 5201 Woodward Dr., Stevens Point WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBE

Trailing 12 months

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

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