FDA.reportPublic FDA data

Ovation

Primary DI
00860009854529
Brand
Ovation
Company
Body Balance System, LLC
Model
ULT
Device description
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.
Published
2023-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009854529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009854529008600098545298600098545290860009854529

GMDN Terms#

Term, Definition table
TermDefinition
Red/infrared light phototherapy unitAn electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Handling Environment Temperature65 Degrees Fahrenheit85 Degrees Fahrenheit
Storage Environment Humidity0 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Temperature65 Degrees Fahrenheit85 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9412238628dr.kate@integralhealingwellness.com
8152694837xx@xx.com
5853151827lisa.stantz@gmail.com
6083301518familycarechiro@hotmail.com
4158474468stsimon@simonequity.com
2818988738jd@hytorctexas.com
5054700491sunshinespowerglow@gmail.com
1111111111drgoodman27@gmail.com
4692352987lbates@canyonranch.com
9034072102jswank25@yahoo.com
4022103495drgoss@omahawellnesscenter.com
2487095635brittanytrinity@gmail.com
4327155690tnchiro@gmail.com
7572873208travistillson@gmail.com
4233354150jonm@gamefitgym.com
5617798886lindasingerisland@gmail.com
1111111111lauxerz@me.com
6135998509sonicwavefitness@gmail.com
4073733883alexfink@me.com
6505494919admin@therecoverzone.com

Regulatory Flags#

DUNS number
876724449
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009854574PremierRLTPremierRLT2025-03-04
00860009854536OvationULTSST2024-06-21
00860009854598OvationULTSST (SGS)2025-10-30
00860009854550ApolloGLOW2025-03-04
00860009854543ApolloARC2025-03-04
00860009854567OvationLITE2025-03-04
00860009854581Foot VitalizerFoot Vitalizer2025-03-04

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B347BDRCK0Bedrock BioscienceLED TECHNOLOGIES INCILY2026-04-23
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B108043POEMVMUS00EMVITALBTL INDUSTRIES LIMITEDILY2025-11-19
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