OvationULT

GUDID 00860009854536

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. This is the same product as the other OvationULT listing however it is for a private labelled distributer.

Body Balance System, LLC

Red/infrared light phototherapy unit
Primary Device ID00860009854536
NIH Device Record Key4131a13f-c48a-4092-b046-08aa4660acc8
Commercial Distribution StatusIn Commercial Distribution
Brand NameOvationULT
Version Model NumberSST
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

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Operating and Storage Conditions

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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
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 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 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 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
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
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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Device Identifiers

Device Issuing AgencyDevice ID
GS100860009854536 [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 Date2024-07-01
Device Publish Date2024-06-21

Devices Manufactured by Body Balance System, LLC

00860009854543 - Apollo2025-03-12
00860009854550 - Apollo2025-03-12
00860009854567 - Ovation2025-03-12
00860009854574 - PremierRLT2025-03-12
00860009854581 - Foot Vitalizer2025-03-12
00860009854536 - OvationULT2024-07-01The 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. This is the same product as the other OvationULT listing however it is for a private labelled distributer.
00860009854536 - OvationULT2024-07-01 The OvationULT is an over-the-counter device that utilizes LED diodes to emit energy in the visible and IR spectrum intended to
00860009854529 - Ovation2023-09-26 The OvationULT is an over-the-counter device that utilizes LED diodes to emit energy in the visible and IR spectrum intended to

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