Richmar TheraTouch

GUDID 80092237621055

LX2 Laser Light Clinical Device with cluster applicator

Compass Richmar, LLC

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• Primary Device ID: 80092237621055
• NIH Device Record Key: 58cae6a1-645a-4ee7-b23c-9e3dd6b91abd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Richmar TheraTouch
• Version Model Number: DQLLLT
• Company DUNS: 080930531
• Company Name: Compass Richmar, LLC
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00092237621059 [Primary]
GS1	80092237621055 [Package]; Contains: 00092237621059; Package: Master Carton [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131259

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: 3
• Public Version Date: 2019-11-11
• Device Publish Date: 2019-02-08

On-Brand Devices [Richmar TheraTouch ]

• 80092237621055: LX2 Laser Light Clinical Device with cluster applicator
• 80092237621475: EX4 E-stim Clinical Device (4-channel)
• 00092237621462: CX4 Combination E-stim/ Ultrasound Clinical Device (4-channel)
• 00092237620397: DX2 Shortwave Diathermy Clinical Device