ELEVATION

Wheelchair, Mechanical

PDG PRODUCT DESIGN GROUP, INC.

The following data is part of a premarket notification filed by Pdg Product Design Group, Inc. with the FDA for Elevation.

Pre-market Notification Details

• Device ID: K140023
• 510k Number: K140023
• Device Name: ELEVATION
• Classification: Wheelchair, Mechanical
• Applicant: PDG PRODUCT DESIGN GROUP, INC. 5905 FAWN LANE Cleveland, OH 44141
• Contact: Edward A Kroll
• Correspondent: Edward A Kroll; PDG PRODUCT DESIGN GROUP, INC. 5905 FAWN LANE Cleveland, OH 44141
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-01-06
• Decision Date: 2014-10-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B829201	K140023	000