Little Wave Arc; Little Wave Flip— 510(k) K223533

Name: FDA 510(k) clearance K223533
Creator: U.S. Food and Drug Administration
Published: 2023-08-31

Substantially Equivalent

Ki Mobility, LLC

FDA 510(k) clearance K223533 for Little Wave Arc; Little Wave Flip, Substantially Equivalent on 2023-08-31. Applicant: Ki Mobility, LLC. Device class: 1.

Clearance details

Applicant: Ki Mobility, LLC
Product code: Code LBE
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 2022-11-23
Decision date: 2023-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stevens Point, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBE

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K863450 — SULKY SPECIAL1986-10-23
K862888 — PERAMBULATOR (STROLLER)1986-08-13
K840250 — CARRIER1984-02-09
K820591 — MECHANICAL CHAIR1982-03-15

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K062660 — CATALYSY2006-10-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.