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FDA 510(k)

ENSO (Model 2)

K-Number: K233784 · 2024-02-23

ApplicantHinge Health, Inc.
Decision Date2024-02-23
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ENSO (Model 2) is a medical device manufactured by Hinge Health, Inc.. It received FDA 510(k) clearance on 2024-02-23 under approval number K233784. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENSO (Model 2)?

ENSO (Model 2) is a medical device that received FDA 510(k) clearance on 2024-02-23. It is manufactured by Hinge Health, Inc.. The 510(k) number is K233784.

When was ENSO (Model 2) approved by the FDA?

ENSO (Model 2) received FDA 510(k) clearance on 2024-02-23, under approval number K233784.

What company makes ENSO (Model 2)?

ENSO (Model 2) is manufactured by Hinge Health, Inc..

What is the FDA product code for ENSO (Model 2)?

The FDA product code for ENSO (Model 2) is NUH.

Other Devices by Hinge Health, Inc.

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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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