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FDA 510(k)

Ki Power Tilt System

K-Number: K201869 · 2023-09-05

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

Device Summary

Ki Power Tilt System 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 2023-09-05 under 510(k) number K201869. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ki Power Tilt System?

Ki Power Tilt System is a medical device that received FDA 510(k) clearance on 2023-09-05. The listed applicant is Ki Mobility, LLC. The 510(k) number is K201869.

When did Ki Power Tilt System receive FDA 510(k) clearance?

Ki Power Tilt System received FDA 510(k) clearance on 2023-09-05, under 510(k) number K201869.

Who is the listed applicant for Ki Power Tilt System?

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 Ki Power Tilt System?

The FDA product code for Ki Power Tilt System is ITI.

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.

K200583Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTLK223533Little Wave Arc; Little Wave FlipK223527Little Wave Clik, Rogue XP, Little Wave XP, Spark

Related Devices (Code: ITI)

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.

K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.K261396Electric WheelchairNingbo Resshidi Medical Devices Co., Ltd.K261164Electric wheelchair (XW-LY007 )Yongkang Ruihe Metal Product Co., Ltd.K260937Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)Shanghai Waylong Intelligent Technology Co.,LtdK253812Power Wheelchair (W5915B, W5915C, W5915D)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260335Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology Co., Ltd.

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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