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FDA 510(k)

THE ADDITION

K-Number: K102683 · 2011-01-06

Decision Date2011-01-06
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE ADDITION is the device name listed in this FDA 510(k) record. The listed applicant is Ob The-Addition, LLC. It received FDA 510(k) clearance on 2011-01-06 under 510(k) number K102683. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ADDITION?

THE ADDITION is a medical device that received FDA 510(k) clearance on 2011-01-06. The listed applicant is Ob The-Addition, LLC. The 510(k) number is K102683.

When did THE ADDITION receive FDA 510(k) clearance?

THE ADDITION received FDA 510(k) clearance on 2011-01-06, under 510(k) number K102683.

Who is the listed applicant for THE ADDITION?

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

What is the FDA product code for THE ADDITION?

The FDA product code for THE ADDITION is MUI.

Related Clinical Trials

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.

Related Devices (Code: MUI)

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.

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