Cleared Traditional

K001800 - ACCUWARM EMG HEAT LAMP

K001800 is an FDA 510(k) clearance for ACCUWARM EMG HEAT LAMP, manufactured by Rjl Associates, LLC. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K001800 · Rjl Associates, LLC · Neurology device
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Sep 2000
Decision
90d
Days
Class 2
Risk

K001800 is an FDA 510(k) clearance for the ACCUWARM EMG HEAT LAMP. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Rjl Associates, LLC (Waterford, US). The FDA issued a Cleared decision on September 12, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K001800

510(k) Number K001800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2000
Decision Date September 12, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 149d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 74
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K001800.
PHYSICAL MONITORING REGISTRATION UNIT
K022719 · Maryrose Cusimano, Ph.D./Phil Reaston · Nov 2002
NEUROPACK MICRO, MODEL MED-9100A SERIES
K010590 · Nihon Kohden America, Inc. · Jun 2001
COMBINED PHYSIOLOGICAL MONITORING SYSTEM
K002104 · Maryrose Cusimano, Ph.D. & Scott Zeff · Oct 2000
NEURO SCAN MEDICAL SYSTEMS A4000
K001562 · Neuro Scan Labs · Aug 2000
NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)
K000812 · Neurosoft, Inc. · May 2000
MA-300 ELECTROMYOGRAPHY SYSTEM
K000220 · Motion Lab Systems, Inc. · Feb 2000
K001800 · ACCUWARM EMG HEAT LAMP
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