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FDA 510(k)

ROLLS ROLLITE WHEELCHAIR

K-Number: K801557 · 1980-07-21

ApplicantInvacare Corp.
Decision Date1980-07-21
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ROLLS ROLLITE WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corp.. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K801557. 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 ROLLS ROLLITE WHEELCHAIR?

ROLLS ROLLITE WHEELCHAIR is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is Invacare Corp.. The 510(k) number is K801557.

When did ROLLS ROLLITE WHEELCHAIR receive FDA 510(k) clearance?

ROLLS ROLLITE WHEELCHAIR received FDA 510(k) clearance on 1980-07-21, under 510(k) number K801557.

Who is the listed applicant for ROLLS ROLLITE WHEELCHAIR?

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 ROLLS ROLLITE WHEELCHAIR?

The FDA product code for ROLLS ROLLITE WHEELCHAIR 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.

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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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