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FDA 510(k)

CATALYSY

K-Number: K062660 · 2006-10-24

ApplicantKi Mobility, LLC
Decision Date2006-10-24
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CATALYSY 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 2006-10-24 under 510(k) number K062660. 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 CATALYSY?

CATALYSY is a medical device that received FDA 510(k) clearance on 2006-10-24. The listed applicant is Ki Mobility, LLC. The 510(k) number is K062660.

When did CATALYSY receive FDA 510(k) clearance?

CATALYSY received FDA 510(k) clearance on 2006-10-24, under 510(k) number K062660.

Who is the listed applicant for CATALYSY?

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 CATALYSY?

The FDA product code for CATALYSY is IOR.

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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 TTLK201869Ki Power Tilt SystemK223533Little Wave Arc; Little Wave FlipK223527Little Wave Clik, Rogue XP, Little Wave XP, Spark

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.

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbHK261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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.

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