STREET

Wheelchair, Powered

PERMOBIL A.B.

The following data is part of a premarket notification filed by Permobil A.b. with the FDA for Street.

Pre-market Notification Details

• Device ID: K032765
• 510k Number: K032765
• Device Name: STREET
• Classification: Wheelchair, Powered
• Applicant: PERMOBIL A.B. ARVALTSV. 10, BOX 120 Timra, SE S-861 00
• Contact: Bengt Persson
• Correspondent: Bengt Persson; PERMOBIL A.B. ARVALTSV. 10, BOX 120 Timra, SE S-861 00
• Product Code: ITI
• CFR Regulation Number: 890.3860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-09-05
• Decision Date: 2004-01-30
• Summary: summary