Cleared Traditional

K052836 - BODIHEALTH SYSTEM

K052836 is an FDA 510(k) clearance for BODIHEALTH SYSTEM, manufactured by Usa Laser Therapeutics, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 495-day FDA review.

K052836 · Usa Laser Therapeutics, Inc. · Neurology device
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Feb 2007
Decision
495d
Days
Class 2
Risk

K052836 is an FDA 510(k) clearance for the BODIHEALTH SYSTEM. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Usa Laser Therapeutics, Inc. (Houston, US). The FDA issued a Cleared decision on February 13, 2007 after a review of 495 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Usa Laser Therapeutics, Inc. devices

FDA 510(k) Submission Details - K052836

510(k) Number K052836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2005
Decision Date February 13, 2007
Days to Decision 495 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
347d slower than avg
Panel avg: 148d · This submission: 495d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 151
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