N/A

GUDID 80092237616440

5cm Sound Head - 2nd Gen

Roscoe Medical

Physical therapy ultrasound system

• Primary Device ID: 80092237616440
• NIH Device Record Key: 8629c52b-1fb5-454c-bc84-37f8b52491d0
• Commercial Distribution Discontinuation: 2019-04-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: N/A
• Version Model Number: DQ8000W5
• Company DUNS: 022542271
• Company Name: Roscoe Medical
• 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: 440-572-1962
• 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
• Phone: 800-376-7263
• Email: customerservice@compasshealthbrands.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00092237616444 [Primary]
GS1	00092337616443 [Primary]
GS1	80092237616440 [Package]; Contains: 00092237616444; Package: CA [20 Units]; Discontinued: 2019-04-24; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120217

FDA Product Code

• IMG: Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-09-13
• Device Publish Date: 2016-10-12

On-Brand Devices [N/A]

• 80813520011939: InTENSity 10 Digital TENS
• 80813520010772: TENS 3000 Analog
• 80813520010468: Electrode - Foil - 2x2 - White
• 01813520010430: Electrode - Foil - 2 - White
• 80813520010345: K120 Electrode, Poly Bag 2 x
• 00813520010042: Electrode - Foil - 2 - Tan
• 80813520010024: Tan Cloth Electrodes w/ Tyco
• 80092237616440: 5cm Sound Head - 2nd Gen
• 80092237618239: Leadwire
• 00092237618226: SoundCare Plus - Wand, 5 cm
• 00092237618219: SoundCare Plus - Wand, 1 cm
• 80092237617515: InTENSity Twin Stim
• 01092237617389: CX4 & EX4 Clinical Leadwires
• 80092237617379: 78 Single (Combination) Lead
• 01092237617365: 78 Clinical Lead Wires
• 80092237617348: Lead Wires for Quattro 2/2.5 &
• 80092237616761: TwinStim Plus 2nd Edition
• 80092237616754: Twin Stim 2nd - TENS/EMS
• 80092237616747: SoundCare Plus - Professional
• 80092237616709: InTENSity Select Combo -
• 80092237616686: InTENSity IF Combo (TENS/IF)
• 80092237616655: EMS 7500 2nd Gen - Digital EMS
• 80092237616433: 1cm Sound Head - 2nd Gen
• 80092237611629: Quattro 2.5
• 80092237605468: ComboCare E-Stim and
• 80092237617386: CX4 & EX4 Clinical Leadwires
• 80092237617362: 78 Clinical Lead Wires