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FDA 510(k)

Little Wave Arc; Little Wave Flip

K-Number: K223533 · 2023-08-31

ApplicantKi Mobility, LLC
Decision Date2023-08-31
Product CodeLBE
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Little Wave Arc; Little Wave Flip is a medical device manufactured by Ki Mobility, LLC. It received FDA 510(k) clearance on 2023-08-31 under approval 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. It is manufactured by Ki Mobility, LLC. The 510(k) number is K223533.

When was Little Wave Arc; Little Wave Flip approved by the FDA?

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

What company makes Little Wave Arc; Little Wave Flip?

Little Wave Arc; Little Wave Flip is manufactured by Ki Mobility, LLC.

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 Devices by Ki Mobility, LLC

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

Official Source

View on FDA Database →

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

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