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FDA 510(k)

FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR

K-Number: K910747 · 1991-03-21

ApplicantFortress Litestyle
Decision Date1991-03-21
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Fortress Litestyle. It received FDA 510(k) clearance on 1991-03-21 under 510(k) number K910747. 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 FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR?

FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR is a medical device that received FDA 510(k) clearance on 1991-03-21. The listed applicant is Fortress Litestyle. The 510(k) number is K910747.

When did FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR receive FDA 510(k) clearance?

FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR received FDA 510(k) clearance on 1991-03-21, under 510(k) number K910747.

Who is the listed applicant for FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR?

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

What is the FDA product code for FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR?

The FDA product code for FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR is IOR.

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Other records listing Fortress Litestyle 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.

K910751FORTRESS 1600ACV REAR WHEEL DRIVE SCOOTERK910753FORTRESS MODEL SPIRIT 4-WHEEL POWER WHEELCHAIRK910749FORTRESS MODEL 760-V 4 WHEEL POWER WHEELCHAIRK910752FORTRESS LIBERTY MANUAL FOLDING WHEELCHAIRK910748FORTRESS EDGE MANUAL RIGID WHEELCHAIRK910746FORTRESS FREESTYLE II MANUAL FOLDING WHEELCHAIR

View all 8 devices →

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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