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FDA 510(k)

ASTROTILT MANUAL WHEELCHAIR

K-Number: K061475 · 2006-06-14

ApplicantPdg Product Design Group, Inc.
Decision Date2006-06-14
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ASTROTILT MANUAL WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Pdg Product Design Group, Inc.. It received FDA 510(k) clearance on 2006-06-14 under 510(k) number K061475. 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 ASTROTILT MANUAL WHEELCHAIR?

ASTROTILT MANUAL WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2006-06-14. The listed applicant is Pdg Product Design Group, Inc.. The 510(k) number is K061475.

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

ASTROTILT MANUAL WHEELCHAIR received FDA 510(k) clearance on 2006-06-14, under 510(k) number K061475.

Who is the listed applicant for ASTROTILT MANUAL WHEELCHAIR?

The FDA 510(k) record lists Pdg Product Design Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASTROTILT MANUAL WHEELCHAIR?

The FDA product code for ASTROTILT MANUAL WHEELCHAIR is IOR.

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Other records listing Pdg Product Design Group, 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.

K163432Stellar LEAPK063736FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50K990557THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIRK971389ECLIPSE 400 MANUALLY OPERATED WHEELCAIRK970311BENTLEY MANUALLY OPERATED WHEELCHAIRK961743ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR

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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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