ROBO

Vehicle, Motorized 3-wheeled

PERMOBIL A.B.

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

Pre-market Notification Details

• Device ID: K942508
• 510k Number: K942508
• Device Name: ROBO
• Classification: Vehicle, Motorized 3-wheeled
• Applicant: PERMOBIL A.B. BOX 120 Timra, SE S-861 23
• Contact: Bengt Persson
• Correspondent: Bengt Persson; PERMOBIL A.B. BOX 120 Timra, SE S-861 23
• Product Code: INI
• CFR Regulation Number: 890.3800 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-05-26
• Decision Date: 1994-11-07