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FDA 510(k)

KARMA WHEELCHAIR

K-Number: K950195 · 1995-03-07

ApplicantKarman Healthcare, Inc.
Decision Date1995-03-07
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

KARMA WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Karman Healthcare, Inc.. It received FDA 510(k) clearance on 1995-03-07 under 510(k) number K950195. 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 KARMA WHEELCHAIR?

KARMA WHEELCHAIR is a medical device that received FDA 510(k) clearance on 1995-03-07. The listed applicant is Karman Healthcare, Inc.. The 510(k) number is K950195.

When did KARMA WHEELCHAIR receive FDA 510(k) clearance?

KARMA WHEELCHAIR received FDA 510(k) clearance on 1995-03-07, under 510(k) number K950195.

Who is the listed applicant for KARMA WHEELCHAIR?

The FDA 510(k) record lists Karman Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARMA WHEELCHAIR?

The FDA product code for KARMA WHEELCHAIR 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 Karman Healthcare, Inc. 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.

K002167KARMAN WHEELCHAIRK002202KARMAN WHEELCHAIR

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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