N/A

GUDID 80092237616440

5cm Sound Head - 2nd Gen

Roscoe Medical

Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system Physical therapy ultrasound system 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