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FDA 510(k)

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL

K-Number: K200583 · 2023-09-05

ApplicantKi Mobility, LLC
Decision Date2023-09-05
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL is a medical device manufactured by Ki Mobility, LLC. It received FDA 510(k) clearance on 2023-09-05 under approval number K200583. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL?

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL is a medical device that received FDA 510(k) clearance on 2023-09-05. It is manufactured by Ki Mobility, LLC. The 510(k) number is K200583.

When was Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL approved by the FDA?

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL received FDA 510(k) clearance on 2023-09-05, under approval number K200583.

What company makes Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL?

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL is manufactured by Ki Mobility, LLC.

What is the FDA product code for Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL?

The FDA product code for Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL is IOR.

Related Clinical Trials

NCT06671171 Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial COMPLETED

Other Devices by Ki Mobility, LLC

K201869Ki Power Tilt System K223533Little Wave Arc; Little Wave Flip K223527Little Wave Clik, Rogue XP, Little Wave XP, Spark

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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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