FDA 510(k)

FLO-BOOT

K-Number: K003272 · 2001-04-04

Decision Date2001-04-04

Product CodeBXB

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

FLO-BOOT is the device name listed in this FDA 510(k) record. The listed applicant is Discovery Group, LLC. It received FDA 510(k) clearance on 2001-04-04 under 510(k) number K003272. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLO-BOOT?

FLO-BOOT is a medical device that received FDA 510(k) clearance on 2001-04-04. The listed applicant is Discovery Group, LLC. The 510(k) number is K003272.

When did FLO-BOOT receive FDA 510(k) clearance?

FLO-BOOT received FDA 510(k) clearance on 2001-04-04, under 510(k) number K003272.

Who is the listed applicant for FLO-BOOT?

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

What is the FDA product code for FLO-BOOT?

The FDA product code for FLO-BOOT is BXB.

Related Devices (Code: BXB)

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.

K072887G-TRAINER MEDICALAlter-G, Inc.K952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.K951028HAMEX TWONorthern Orthopaedic Products, 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.