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FDA 510(k)

Bigfoot Unity® Diabetes Management System

K-Number: K222280 · 2023-03-01

ApplicantBigfoot Biomedical, Inc.
Decision Date2023-03-01
Product CodeQLG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Bigfoot Unity® Diabetes Management System is the device name listed in this FDA 510(k) record. The listed applicant is Bigfoot Biomedical, Inc.. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K222280. The device is classified under product code QLG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bigfoot Unity® Diabetes Management System?

Bigfoot Unity® Diabetes Management System is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is Bigfoot Biomedical, Inc.. The 510(k) number is K222280.

When did Bigfoot Unity® Diabetes Management System receive FDA 510(k) clearance?

Bigfoot Unity® Diabetes Management System received FDA 510(k) clearance on 2023-03-01, under 510(k) number K222280.

Who is the listed applicant for Bigfoot Unity® Diabetes Management System?

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

What is the FDA product code for Bigfoot Unity® Diabetes Management System?

The FDA product code for Bigfoot Unity® Diabetes Management System is QLG.

Other records listing Bigfoot Biomedical, 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.

K202145Bigfoot Unity Diabetes Management System

Related Devices (Code: QLG)

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.

K223537FreeStyle Libre 2 System, FreeStyle Libre 3 SystemAbbott Diabetes Care, Inc.K213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.K212132FreeStyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc.K210943FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc.K211102FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc.K201761FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)Abbott Diabetes Care, Inc.

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.

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