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FDA 510(k)

TUFFCARE MEDICAL PRODUCTS WHEELCHAIR

K-Number: K894422 · 1989-08-03

ApplicantTuffman Industries
Decision Date1989-08-03
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TUFFCARE MEDICAL PRODUCTS WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Tuffman Industries. It received FDA 510(k) clearance on 1989-08-03 under 510(k) number K894422. 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 TUFFCARE MEDICAL PRODUCTS WHEELCHAIR?

TUFFCARE MEDICAL PRODUCTS WHEELCHAIR is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Tuffman Industries. The 510(k) number is K894422.

When did TUFFCARE MEDICAL PRODUCTS WHEELCHAIR receive FDA 510(k) clearance?

TUFFCARE MEDICAL PRODUCTS WHEELCHAIR received FDA 510(k) clearance on 1989-08-03, under 510(k) number K894422.

Who is the listed applicant for TUFFCARE MEDICAL PRODUCTS WHEELCHAIR?

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

What is the FDA product code for TUFFCARE MEDICAL PRODUCTS WHEELCHAIR?

The FDA product code for TUFFCARE MEDICAL PRODUCTS WHEELCHAIR is IOR.

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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

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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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