Cleared Traditional

PAIN VISION, MODEL PS-2100 (K072882) - FDA 510(k) Clearance

Class I Neurology device.

K072882 · Osachi Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
457d
Days
Class 1
Risk

K072882 is an FDA 510(k) clearance for the PAIN VISION, MODEL PS-2100. Classified as Device, Vibration Threshold Measurement (product code LLN), Class I - General Controls.

Submitted by Osachi Co., Ltd. (Las Vegas, US). The FDA issued a Cleared decision on January 8, 2009 after a review of 457 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1200 - 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 Osachi Co., Ltd. devices

Submission Details

510(k) Number K072882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2007
Decision Date January 08, 2009
Days to Decision 457 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 148d · This submission: 457d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLN Device, Vibration Threshold Measurement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1200
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.