FDA 510(k)

OnX Tough

K-Number: K230445 · 2023-07-14

Decision Date2023-07-14

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

OnX Tough is the device name listed in this FDA 510(k) record. The listed applicant is Sprintray, Inc.. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K230445. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OnX Tough?

OnX Tough is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Sprintray, Inc.. The 510(k) number is K230445.

When did OnX Tough receive FDA 510(k) clearance?

OnX Tough received FDA 510(k) clearance on 2023-07-14, under 510(k) number K230445.

Who is the listed applicant for OnX Tough?

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

What is the FDA product code for OnX Tough?

The FDA product code for OnX Tough is EBI.

Other records listing Sprintray, Inc. as applicant

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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.