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FDA 510(k)

Little Wave Clik, Rogue XP, Little Wave XP, Spark

K-Number: K223527 · 2023-08-31

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

Device Summary

Little Wave Clik, Rogue XP, Little Wave XP, Spark 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 K223527. 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 Little Wave Clik, Rogue XP, Little Wave XP, Spark?

Little Wave Clik, Rogue XP, Little Wave XP, Spark 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 K223527.

When did Little Wave Clik, Rogue XP, Little Wave XP, Spark receive FDA 510(k) clearance?

Little Wave Clik, Rogue XP, Little Wave XP, Spark received FDA 510(k) clearance on 2023-08-31, under 510(k) number K223527.

Who is the listed applicant for Little Wave Clik, Rogue XP, Little Wave XP, Spark?

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 Clik, Rogue XP, Little Wave XP, Spark?

The FDA product code for Little Wave Clik, Rogue XP, Little Wave XP, Spark is IOR.

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 SystemK200583Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTLK223533Little Wave Arc; Little Wave Flip

Related Devices (Code: IOR)

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.

K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K252370GEN 4 JOY WheelchairFree Wheelchair MissionK261076Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K261075Manual Wheelchair (MS01);Manual Wheelchair (MA01)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K260849ICON 35; ICON 45; ICON 60; ICON 30FAFRehasense USA, Inc.K260642Manual Wheelchair (LW01108)Anhui Longway Medical 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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