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FDA 510(k)

KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS

K-Number: K982336 · 1998-08-21

ApplicantInvacare Corp.
Decision Date1998-08-21
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corp.. It received FDA 510(k) clearance on 1998-08-21 under 510(k) number K982336. 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 KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS?

KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS is a medical device that received FDA 510(k) clearance on 1998-08-21. The listed applicant is Invacare Corp.. The 510(k) number is K982336.

When did KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS receive FDA 510(k) clearance?

KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS received FDA 510(k) clearance on 1998-08-21, under 510(k) number K982336.

Who is the listed applicant for KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS?

The FDA 510(k) record lists Invacare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS?

The FDA product code for KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS is IOR.

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Other records listing Invacare Corp. 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.

K071928THE INVACARE FLYER, MODEL IPC 100K070321TWILIGHT FULL FACE MASKK062402EASYSTAND EVOLVK061874INVACARE'S TWILIGHT II NASAL MASKSK033819INVACARE 3G TARSYSK031176INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000

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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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