Cleared Traditional

K924513 - LIDO(R) LINEA

K924513 is an FDA 510(k) clearance for LIDO LINEA, manufactured by Loredan Biomedical, Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K924513 · Loredan Biomedical, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
208d
Days
Class 1
Risk

K924513 is an FDA 510(k) clearance for the LIDO(R) LINEA. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Loredan Biomedical, Inc. (West Sacramento, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 208 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 Loredan Biomedical, Inc. devices

FDA 510(k) Submission Details - K924513

510(k) Number K924513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1992
Decision Date March 31, 1993
Days to Decision 208 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
93d slower than avg
Panel avg: 115d · This submission: 208d
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 39
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