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

FDA 510(k)

Indego(R)

K-Number: K173530 · 2018-01-31

ApplicantParker-Hannifin Corporation
Decision Date2018-01-31
Product CodePHL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Indego(R) is the device name listed in this FDA 510(k) record. The listed applicant is Parker-Hannifin Corporation. It received FDA 510(k) clearance on 2018-01-31 under 510(k) number K173530. 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(R)?

Indego(R) is a medical device that received FDA 510(k) clearance on 2018-01-31. The listed applicant is Parker-Hannifin Corporation. The 510(k) number is K173530.

When did Indego(R) receive FDA 510(k) clearance?

Indego(R) received FDA 510(k) clearance on 2018-01-31, under 510(k) number K173530.

Who is the listed applicant for Indego(R)?

The FDA 510(k) record lists Parker-Hannifin Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Indego(R)?

The FDA product code for Indego(R) is PHL.

Other records listing Parker-Hannifin Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241465Midas Flowmeter; eAVSK223452Nitronox Scavenger PlusK202480Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50K171334IndegoK161731Cleveland Multiport Ventricular Catheter SetK152416Indego

View all 7 devices →

Related Devices (Code: PHL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260381EveWandercraft SASK250904Atalante XWandercraft SASK241822ReWalk® 7 Personal Exoskeleton (50-20-0005)Rewalk Robotics Ltd. Dba LifewardK233695Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc.K232077Atalante XWandercraft SASK221696ReWalk P6.0Re Walk Robotics , 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.

↑