Utopia Gear
GUDID 00862081000313
MIDWESTERN SOLUTIONS
Physical therapy transcutaneous neuromuscular electrical stimulation system| Primary Device ID | 00862081000313 |
| NIH Device Record Key | e6dc9358-8a15-4df9-9d45-bf0cc76bbecd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Utopia Gear |
| Version Model Number | Massage Pro Mini |
| 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 | false |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862081000313 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141260
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 | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2016-09-27 |
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 |
Trademark Results [Utopia Gear]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UTOPIA GEAR 85547708 not registered Dead/Abandoned |
Midwestern Solutions 2012-02-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.