Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Indego

K-Number: K152416 · 2016-02-26

ApplicantParker Hannifin Corporation
Decision Date2016-02-26
Product CodePHL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Indego is a medical device manufactured by Parker Hannifin Corporation. It received FDA 510(k) clearance on 2016-02-26 under approval number K152416. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Indego?

Indego is a medical device that received FDA 510(k) clearance on 2016-02-26. It is manufactured by Parker Hannifin Corporation. The 510(k) number is K152416.

When was Indego approved by the FDA?

Indego received FDA 510(k) clearance on 2016-02-26, under approval number K152416.

What company makes Indego?

Indego is manufactured by Parker Hannifin Corporation.

What is the FDA product code for Indego?

The FDA product code for Indego is PHL.

Other Devices by Parker Hannifin Corporation

K171334Indego K223452Nitronox Scavenger Plus K241465Midas Flowmeter; eAVS

Related Devices (Code: PHL)

K160987ReWalk(TM)Rewalk Robotics, Inc. K161443Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. K143690Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. K171909HAL for Medical Use (Lower Limb Type)Cyberdyne, Inc. K171334IndegoParker Hannifin Corporation K181294Honda Walking Assist DeviceHonda Motor Company, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑