Ovation

GUDID 00860009854567

Body Balance System, LLC

Red/infrared light phototherapy unit

• Primary Device ID: 00860009854567
• NIH Device Record Key: bd4003cd-065b-4f21-af30-a4746bb4c38f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ovation
• Version Model Number: LITE
• Company DUNS: 876724449
• Company Name: Body Balance System, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009854567 [Primary]

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-12
• Device Publish Date: 2025-03-04

On-Brand Devices [Ovation]

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