Indego

Powered Exoskeleton

Parker Hannifin Corporation

The following data is part of a premarket notification filed by Parker Hannifin Corporation with the FDA for Indego.

Pre-market Notification Details

• Device ID: K171334
• 510k Number: K171334
• Device Name: Indego
• Classification: Powered Exoskeleton
• Applicant: Parker Hannifin Corporation 1390 E. Highland Road Macedonia, OH 44056
• Contact: Achilleas Dorotheou
• Correspondent: Audrey Swearingen; Emergo Global Consulting, LLC 2500 Bee Cave Rd, Bldg 1, Suite 300 Austin, TX 78746
• Product Code: PHL
• CFR Regulation Number: 890.3480 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-05-08
• Decision Date: 2017-09-08
• Summary: summary