FDA 510(k)

Little Wave Arc; Little Wave Flip

K-Number: K223533 · 2023-08-31

Decision Date2023-08-31

Product CodeLBE

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Little Wave Arc; Little Wave Flip is the device name listed in this FDA 510(k) record. The listed applicant is Ki Mobility, LLC. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K223533. The device is classified under product code LBE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Little Wave Arc; Little Wave Flip?

Little Wave Arc; Little Wave Flip is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Ki Mobility, LLC. The 510(k) number is K223533.

When did Little Wave Arc; Little Wave Flip receive FDA 510(k) clearance?

Little Wave Arc; Little Wave Flip received FDA 510(k) clearance on 2023-08-31, under 510(k) number K223533.

Who is the listed applicant for Little Wave Arc; Little Wave Flip?

The FDA 510(k) record lists Ki Mobility, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Little Wave Arc; Little Wave Flip?

The FDA product code for Little Wave Arc; Little Wave Flip is LBE.

Other records listing Ki Mobility, LLC as applicant

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.

K201869Ki Power Tilt System K200583Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL K223527Little Wave Clik, Rogue XP, Little Wave XP, Spark

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.