OvationULT

GUDID 00860009854598

OvationULT private labelled for SST with SGS certification.

Body Balance System, LLC

Red/infrared light phototherapy unit

• Primary Device ID: 00860009854598
• NIH Device Record Key: 77023609-5732-4382-ad0a-a7ce15fca1c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OvationULT
• Version Model Number: SST (SGS)
• 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

Customer Support Contacts

• Phone: 2703173980
• Email: frank.davis@globrands.com
• Phone: 2703173980
• Email: frank.davis@globrands.com
• Phone: 2703173980
• Email: frank.davis@globrands.com
• Phone: 2703173980
• Email: frank.davis@globrands.com
• Phone: 2703173980
• Email: frank.davis@globrands.com
• Phone: 2703173980
• Email: frank.davis@globrands.com
• Phone: 2703173980
• Email: frank.davis@globrands.com
• Phone: 2703173980
• Email: frank.davis@globrands.com
• Phone: 2703173980
• Email: frank.davis@globrands.com
• Phone: 2703173980
• Email: frank.davis@globrands.com
• Phone: 2703173980
• Email: frank.davis@globrands.com
• Phone: 2703173980
• Email: frank.davis@globrands.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009854598 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-30
• Device Publish Date: 2025-10-30

On-Brand Devices [OvationULT]

• 00860009854536: The OvationULT is an over-the-counter device that utilizes LED diodes to emit energy in the visi
• 00860009854598: OvationULT private labelled for SST with SGS certification.