Cleared Traditional

K003272 - FLO-BOOT

K003272 is an FDA 510(k) clearance for FLO-BOOT, manufactured by Discovery Group, LLC. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K003272 · Discovery Group, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
168d
Days
Class 1
Risk

K003272 is an FDA 510(k) clearance for the FLO-BOOT. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Discovery Group, LLC (Richmond, US). The FDA issued a Cleared decision on April 4, 2001 after a review of 168 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Discovery Group, LLC devices

FDA 510(k) Submission Details - K003272

510(k) Number K003272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2000
Decision Date April 04, 2001
Days to Decision 168 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 115d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

BXB Device Classification - Class 1, General Controls

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BXB Exerciser, Powered

All 38
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