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FDA 510(k)

Stellar LEAP

K-Number: K163432 · 2017-06-27

ApplicantPdg Product Design Group, Inc.
Decision Date2017-06-27
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Stellar LEAP 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 2017-06-27 under 510(k) number K163432. 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 Stellar LEAP?

Stellar LEAP is a medical device that received FDA 510(k) clearance on 2017-06-27. The listed applicant is Pdg Product Design Group, Inc.. The 510(k) number is K163432.

When did Stellar LEAP receive FDA 510(k) clearance?

Stellar LEAP received FDA 510(k) clearance on 2017-06-27, under 510(k) number K163432.

Who is the listed applicant for Stellar LEAP?

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 Stellar LEAP?

The FDA product code for Stellar LEAP is IOR.

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.

K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K252370GEN 4 JOY WheelchairFree Wheelchair MissionK261076Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K261075Manual Wheelchair (MS01);Manual Wheelchair (MA01)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K260849ICON 35; ICON 45; ICON 60; ICON 30FAFRehasense USA, Inc.K260642Manual Wheelchair (LW01108)Anhui Longway Medical Technology 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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