Cleared Traditional

K001056 - OLYMPIC WARM-UP

K001056 is an FDA 510(k) clearance for OLYMPIC WARM-UP, manufactured by Olympic Medical Corp.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K001056 · Olympic Medical Corp. · Physical Medicine device
Download Printable Device Report (PDF)
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Sep 2000
Decision
179d
Days
Class 2
Risk

K001056 is an FDA 510(k) clearance for the OLYMPIC WARM-UP. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on September 29, 2000 after a review of 179 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - 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 Olympic Medical Corp. devices

FDA 510(k) Submission Details - K001056

510(k) Number K001056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2000
Decision Date September 29, 2000
Days to Decision 179 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 115d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ILY Lamp, Infrared, Therapeutic Heating

All 27
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K001056.
SOLARIS D890 THERAPY PROBE
K040729 · Dynatronics Corp. · Jun 2004
RICH-MAR AUTOPRISM INFRARED LAMP
K040679 · Rich-Mar Corp. · May 2004
SURGICAL PATIENT WARMER, MODEL PW820 JHU
K022609 · Fisher &Paykel Healthcare , Ltd. · Mar 2003
PATIENT WARMER- MODEL PW810
K982636 · Fisher &Paykel Healthcare , Ltd. · Oct 1998
DERMATHERM 100
K980607 · New Star Lasers, Inc. · Apr 1998
OLYMPIC WARM-LAMP
K932881 · Olympic Medical Corp. · Jan 1994