CRAWLER

Board, Scooter, Prone

MADDAK, INC.

The following data is part of a premarket notification filed by Maddak, Inc. with the FDA for Crawler.

Pre-market Notification Details

• Device ID: K841695
• 510k Number: K841695
• Device Name: CRAWLER
• Classification: Board, Scooter, Prone
• Applicant: MADDAK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KNL
• CFR Regulation Number: 890.5370 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-04-23
• Decision Date: 1984-05-10