PANDA

Wheelchair, Mechanical

ETAC US, INC.

The following data is part of a premarket notification filed by Etac Us, Inc. with the FDA for Panda.

Pre-market Notification Details

• Device ID: K923428
• 510k Number: K923428
• Device Name: PANDA
• Classification: Wheelchair, Mechanical
• Applicant: ETAC US, INC. 2325 PARKLAWN DRIVE, SUITE P Waukesha, WI 53186
• Contact: Melody B Dill
• Correspondent: Melody B Dill; ETAC US, INC. 2325 PARKLAWN DRIVE, SUITE P Waukesha, WI 53186
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-07-13
• Decision Date: 1993-03-04