Utopia Gear

GUDID 00862081000375

MIDWESTERN SOLUTIONS

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00862081000375
• NIH Device Record Key: 8cbcfc41-3a72-4bcd-badc-7ecc43c4d71b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Utopia Gear
• Version Model Number: Pro 4.0
• Company DUNS: 048681673
• Company Name: MIDWESTERN SOLUTIONS
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862081000368 [Primary]
GS1	00862081000375 [Package]; Contains: 00862081000368; Package: CASE [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143268

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

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: 2021-09-01
• Device Publish Date: 2021-08-24

On-Brand Devices [Utopia Gear]

• 00862081000344: XL Electrode Pads
• 00862081000337: Large Electrode Pads
• 00862081000320: Massage Pro 2.0
• 00862081000313: Massage Pro Mini
• 00862081000306: Massage Pro 3.0
• 00862081000375: Pro 4.0