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FDA 510(k)

SWEDE ELITE, MECHANICAL WHEELCHAIR

K-Number: K883275 · 1988-08-18

ApplicantEtac Us, Inc.
Decision Date1988-08-18
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SWEDE ELITE, MECHANICAL 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 1988-08-18 under 510(k) number K883275. 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 ELITE, MECHANICAL WHEELCHAIR?

SWEDE ELITE, MECHANICAL WHEELCHAIR is a medical device that received FDA 510(k) clearance on 1988-08-18. The listed applicant is Etac Us, Inc.. The 510(k) number is K883275.

When did SWEDE ELITE, MECHANICAL WHEELCHAIR receive FDA 510(k) clearance?

SWEDE ELITE, MECHANICAL WHEELCHAIR received FDA 510(k) clearance on 1988-08-18, under 510(k) number K883275.

Who is the listed applicant for SWEDE ELITE, MECHANICAL 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 ELITE, MECHANICAL WHEELCHAIR?

The FDA product code for SWEDE ELITE, MECHANICAL 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.

K923428PANDAK914610SWEDE CROSS MANUAL 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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