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FDA 510(k)

SWEDE CROSS MANUAL WHEELCHAIR

K-Number: K914610 · 1991-11-29

ApplicantEtac Us, Inc.
Decision Date1991-11-29
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SWEDE CROSS MANUAL WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Etac Us, Inc.. It received FDA 510(k) clearance on 1991-11-29 under 510(k) number K914610. 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 SWEDE CROSS MANUAL WHEELCHAIR?

SWEDE CROSS MANUAL WHEELCHAIR is a medical device that received FDA 510(k) clearance on 1991-11-29. The listed applicant is Etac Us, Inc.. The 510(k) number is K914610.

When did SWEDE CROSS MANUAL WHEELCHAIR receive FDA 510(k) clearance?

SWEDE CROSS MANUAL WHEELCHAIR received FDA 510(k) clearance on 1991-11-29, under 510(k) number K914610.

Who is the listed applicant for SWEDE CROSS MANUAL WHEELCHAIR?

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

What is the FDA product code for SWEDE CROSS MANUAL WHEELCHAIR?

The FDA product code for SWEDE CROSS MANUAL 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.

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Other records listing Etac Us, 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.

K923428PANDAK883275SWEDE ELITE, MECHANICAL WHEELCHAIRK875035SWEDE PETITE (WHEELCHAIR)K875034SWEDE CHAMP (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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