Richmar TheraTouch

GUDID 00092237620397

DX2 Shortwave Diathermy Clinical Device

Compass Richmar, LLC

Short-wave diathermy treatment system generator

• Primary Device ID: 00092237620397
• NIH Device Record Key: 4c1fc207-9b88-4ebc-8872-51797218cf6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Richmar TheraTouch
• Version Model Number: DQSWD2
• 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	00092237620397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131899

FDA Product Code

• IMJ: Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

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: 2019-03-11
• 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