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FDA 510(k)

Digital Routines

K-Number: K221924 · 2023-03-15

Decision Date2023-03-15
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Digital Routines is the device name listed in this FDA 510(k) record. The listed applicant is Gnc Holdings, LLC. It received FDA 510(k) clearance on 2023-03-15 under 510(k) number K221924. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Routines?

Digital Routines is a medical device that received FDA 510(k) clearance on 2023-03-15. The listed applicant is Gnc Holdings, LLC. The 510(k) number is K221924.

When did Digital Routines receive FDA 510(k) clearance?

Digital Routines received FDA 510(k) clearance on 2023-03-15, under 510(k) number K221924.

Who is the listed applicant for Digital Routines?

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

What is the FDA product code for Digital Routines?

The FDA product code for Digital Routines is NDC.

Related Devices (Code: NDC)

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.

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.