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FDA 510(k)

EzOrtho v1.3

K-Number: K220003 · 2022-02-23

ApplicantEwoosoft Co., Ltd.
Decision Date2022-02-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EzOrtho v1.3 is the device name listed in this FDA 510(k) record. The listed applicant is Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2022-02-23 under 510(k) number K220003. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EzOrtho v1.3?

EzOrtho v1.3 is a medical device that received FDA 510(k) clearance on 2022-02-23. The listed applicant is Ewoosoft Co., Ltd.. The 510(k) number is K220003.

When did EzOrtho v1.3 receive FDA 510(k) clearance?

EzOrtho v1.3 received FDA 510(k) clearance on 2022-02-23, under 510(k) number K220003.

Who is the listed applicant for EzOrtho v1.3?

The FDA 510(k) record lists Ewoosoft Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EzOrtho v1.3?

The FDA product code for EzOrtho v1.3 is LLZ.

Other records listing Ewoosoft Co., Ltd. as applicant

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Related Devices (Code: LLZ)

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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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