ACTIVX

Wheelchair, Mechanical

ADORNO ROGERS TECHNOLOGY

The following data is part of a premarket notification filed by Adorno Rogers Technology with the FDA for Activx.

Pre-market Notification Details

• Device ID: K984367
• 510k Number: K984367
• Device Name: ACTIVX
• Classification: Wheelchair, Mechanical
• Applicant: ADORNO ROGERS TECHNOLOGY 101 WEST 6TH ST., SUITE 409 Austin, TX 78701 -2933
• Contact: Paul Gibb
• Correspondent: Paul Gibb; ADORNO ROGERS TECHNOLOGY 101 WEST 6TH ST., SUITE 409 Austin, TX 78701 -2933
• Product Code: IOR
• CFR Regulation Number: 890.3850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-12-07
• Decision Date: 1999-01-28
• Summary: summary