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FDA 510(k)

BENTLEY MANUALLY OPERATED WHEELCHAIR

K-Number: K970311 · 1997-02-14

ApplicantPdg Product Design Group, Inc.
Decision Date1997-02-14
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BENTLEY MANUALLY OPERATED 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 1997-02-14 under 510(k) number K970311. 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 BENTLEY MANUALLY OPERATED WHEELCHAIR?

BENTLEY MANUALLY OPERATED WHEELCHAIR is a medical device that received FDA 510(k) clearance on 1997-02-14. The listed applicant is Pdg Product Design Group, Inc.. The 510(k) number is K970311.

When did BENTLEY MANUALLY OPERATED WHEELCHAIR receive FDA 510(k) clearance?

BENTLEY MANUALLY OPERATED WHEELCHAIR received FDA 510(k) clearance on 1997-02-14, under 510(k) number K970311.

Who is the listed applicant for BENTLEY MANUALLY OPERATED 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 BENTLEY MANUALLY OPERATED WHEELCHAIR?

The FDA product code for BENTLEY MANUALLY OPERATED WHEELCHAIR is IOR.

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Other records listing Pdg Product Design Group, Inc. as applicant

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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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