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FDA 510(k)

Indego

K-Number: K171334 · 2017-09-08

ApplicantParker Hannifin Corporation
Decision Date2017-09-08
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 2017-09-08 under approval number K171334. 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 2017-09-08. It is manufactured by Parker Hannifin Corporation. The 510(k) number is K171334.

When was Indego approved by the FDA?

Indego received FDA 510(k) clearance on 2017-09-08, under approval number K171334.

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

K152416Indego 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. K152416IndegoParker Hannifin Corporation K171909HAL for Medical Use (Lower Limb Type)Cyberdyne, Inc. 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.

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