FDA 510(k)

EksoNR

K-Number: K200574 · 2020-06-19

Decision Date2020-06-19

Product CodePHL

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

EksoNR is the device name listed in this FDA 510(k) record. The listed applicant is Ekso Bionics, Inc.. It received FDA 510(k) clearance on 2020-06-19 under 510(k) number K200574. 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 EksoNR?

EksoNR is a medical device that received FDA 510(k) clearance on 2020-06-19. The listed applicant is Ekso Bionics, Inc.. The 510(k) number is K200574.

When did EksoNR receive FDA 510(k) clearance?

EksoNR received FDA 510(k) clearance on 2020-06-19, under 510(k) number K200574.

Who is the listed applicant for EksoNR?

The FDA 510(k) record lists Ekso Bionics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EksoNR?

The FDA product code for EksoNR is PHL.

Other records listing Ekso Bionics, Inc. 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.

K220988EksoNR K161443Ekso™ (version 1.1) and Ekso GT™ (version 1.2)K143690Ekso™ (version 1.1) and Ekso GT™ (version 1.2)

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Official Source

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