Omnipad Light Therapy, Dual 5x7 Pads

GUDID 00858703006061

Infrared lamp for therapeutic healing

ACCELERATED CARE PLUS CORP

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 00858703006061
• NIH Device Record Key: c8b9e4f9-0ae1-4fe3-ad67-c3a65870bbb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnipad Light Therapy, Dual 5x7 Pads
• Version Model Number: 76896
• Company DUNS: 828331616
• Company Name: ACCELERATED CARE PLUS CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-350-1100
• Email: customersupport@acplus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858703006061 [Primary]
GS1	10858703006068 [Package]; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060191

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: 5
• Public Version Date: 2020-03-10
• Device Publish Date: 2016-08-16

On-Brand Devices [Omnipad Light Therapy, Dual 5x7 Pads]

• 10858703006906: Infrared lamp for therapeutic healing
• 00858703006061: Infrared lamp for therapeutic healing