Phoenix

Powered Exoskeleton

US Bionics, Inc. (DBA SuitX)

The following data is part of a premarket notification filed by Us Bionics, Inc. (dba Suitx) with the FDA for Phoenix.

Pre-market Notification Details

• Device ID: K183152
• 510k Number: K183152
• Device Name: Phoenix
• Classification: Powered Exoskeleton
• Applicant: US Bionics, Inc. (DBA SuitX) 4512 Hollis Street Emeryville, CA 94608
• Contact: Kelly Mettler
• Correspondent: Allison C. Komiyama; AcKnowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110
• Product Code: PHL
• CFR Regulation Number: 890.3480 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-11-14
• Decision Date: 2019-04-17