Kudu

Wheelchair, Mechanical

R82 A/S

The following data is part of a premarket notification filed by R82 A/s with the FDA for Kudu.

Pre-market Notification Details

• Device ID: K151492
• 510k Number: K151492
• Device Name: Kudu
• Classification: Wheelchair, Mechanical
• Applicant: R82 A/S Parallelvej 3 Gedved, DK Dk-8751
• Contact: Kent Rasmussen
• Correspondent: Ulla Lange; R82 A/S Parallelvej 3 Gedved, DK Dk-8751
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-06-03
• Decision Date: 2016-05-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05707292948656	K151492	000
05707292771957	K151492	000
05707292805232	K151492	000
05707292808424	K151492	000
05707292811615	K151492	000
05707292811714	K151492	000
05707292830463	K151492	000
05707292831071	K151492	000
05707292867292	K151492	000
05707292926340	K151492	000
05707292928085	K151492	000
05707292932372	K151492	000
05707292933904	K151492	000
05707292938435	K151492	000
05707292946515	K151492	000
05707292929693	K151492	000