OvationULT

Basic Information

• Brand Name: OvationULT
• Primary DI: 00860009854536
• Version / Model: SST
• Company Name: Body Balance System, LLC
• Labeler DUNS: 876724449
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-21
• Public Version: 9
• Public Version Date: 2026-01-30
• Public Version Status: Update
• Public Device Record Key: 4131a13f-c48a-4092-b046-08aa4660acc8

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65723	Red/infrared light phototherapy unit	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009854536	GS1

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Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 0 – 50 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 65 – 85 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 65 – 85 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 0 – 50 Percent (%) Relative Humidity