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: K152416
• 510k Number: K152416
• Device Name: Indego
• Classification: Powered Exoskeleton
• Applicant: PARKER HANNIFIN CORPORATION 1390 E. HIGHLAND ROAD Macedonia, OH 44056
• Contact: Achilleas Dorotheou
• Correspondent: Richard A Vincins; EMERGO 816 CONGRESS AVENUE, SUITE 1400 Austin, TX 78701
• Product Code: PHL
• CFR Regulation Number: 890.3480 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-08-26
• Decision Date: 2016-02-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M704501100000	K152416	000