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FDA 510(k)

MECHANICAL WHEELCHAIR- IMPACT

K-Number: K945152 · 1995-05-01

ApplicantColours 'N Motion
Decision Date1995-05-01
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MECHANICAL WHEELCHAIR- IMPACT is the device name listed in this FDA 510(k) record. The listed applicant is Colours 'N Motion. It received FDA 510(k) clearance on 1995-05-01 under 510(k) number K945152. 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 MECHANICAL WHEELCHAIR- IMPACT?

MECHANICAL WHEELCHAIR- IMPACT is a medical device that received FDA 510(k) clearance on 1995-05-01. The listed applicant is Colours 'N Motion. The 510(k) number is K945152.

When did MECHANICAL WHEELCHAIR- IMPACT receive FDA 510(k) clearance?

MECHANICAL WHEELCHAIR- IMPACT received FDA 510(k) clearance on 1995-05-01, under 510(k) number K945152.

Who is the listed applicant for MECHANICAL WHEELCHAIR- IMPACT?

The FDA 510(k) record lists Colours 'N Motion as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MECHANICAL WHEELCHAIR- IMPACT?

The FDA product code for MECHANICAL WHEELCHAIR- IMPACT is IOR.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Colours 'N Motion 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.

K071444MECHANICAL WHEELCHAIR - L-FRAME SERIESK030017CHUMPK010823SPAZZK984354MECHANICAL WHEELCHAIRK945148MECHANICAL WHEELCHAIR- AVENGERK945151MECHANICAL WHEELCHAIR- G-FORCE

View all 12 devices →

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

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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