Ovation

GUDID 00860009854529

The OvationULT is an over-the-counter device that utilizes LED diodes to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.

Body Balance System, LLC

Red/infrared light phototherapy unit
Primary Device ID00860009854529
NIH Device Record Key5cf95e82-e23d-41b5-873b-2e3d4c179894
Commercial Distribution StatusIn Commercial Distribution
Brand NameOvation
Version Model NumberULT
Company DUNS876724449
Company NameBody Balance System, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
Emaildr.kate@integralhealingwellness.com
Phone9412238628
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Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
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Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
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Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Handling Environment TemperatureBetween 65 Degrees Fahrenheit and 85 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100860009854529 [Primary]

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-26
Device Publish Date2023-09-18

On-Brand Devices [Ovation]

00860009854529The OvationULT is an over-the-counter device that utilizes LED diodes to emit energy in the visi
00860009854567LITE

Trademark Results [Ovation]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OVATION
OVATION
98752239 not registered Live/Pending
Breland Companies, LLC
2024-09-16
OVATION
OVATION
98608732 not registered Live/Pending
LEADCAR SYSTEMS, INC.
2024-06-19
OVATION
OVATION
98608730 not registered Live/Pending
LEADCAR SYSTEMS, INC.
2024-06-19
OVATION
OVATION
98608726 not registered Live/Pending
LEADCAR SYSTEMS, INC.
2024-06-19
OVATION
OVATION
98552277 not registered Live/Pending
VIETNAM COFO TIRES COMPANY LIMITED
2024-05-15
OVATION
OVATION
98482639 not registered Live/Pending
Meyers Group Partners, LLC
2024-04-03
OVATION
OVATION
98443950 not registered Live/Pending
LEADCAR SYSTEMS, INC.
2024-03-11
OVATION
OVATION
98443949 not registered Live/Pending
LEADCAR SYSTEMS, INC.
2024-03-11
OVATION
OVATION
98443875 not registered Live/Pending
LEADCAR SYSTEMS, INC.
2024-03-11
OVATION
OVATION
98424694 not registered Live/Pending
Global Payments Inc.
2024-02-28
OVATION
OVATION
98397416 not registered Live/Pending
Senior Market Sales, LLC
2024-02-08
OVATION
OVATION
98362991 not registered Live/Pending
OVATION HOME INSURANCE EXCHANGE
2024-01-18

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