Mountain Valley
GUDID 80092237618864
Ultra Cure Pro PLUS
COMPASS HEALTH BRANDS CORP.
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 Physical therapy ultrasound system Physical therapy ultrasound system| Primary Device ID | 80092237618864 |
| NIH Device Record Key | fc384d07-7ddb-4b95-a1a9-dc5ab4854c5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mountain Valley |
| Version Model Number | DU3038 |
| Company DUNS | 827221698 |
| Company Name | COMPASS HEALTH BRANDS CORP. |
| 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 | true |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00092237618868 [Primary] |
| GS1 | 80092237618864 [Package] Contains: 00092237618868 Package: CA [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092627
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-13 |
Devices Manufactured by COMPASS HEALTH BRANDS CORP.
| 00092237626009 - HydraTherm | 2024-05-22 HYDRATHERM CONTROL PANEL SCREW REPAIR PART |
| 00092237626016 - HydraTherm | 2024-05-22 HYDRATHERM LID HANDLE SCREW KIT REPAIR PART |
| 00815067012732 - Probasics | 2024-05-22 Ascent Rollator, Cobalt Blue, HT ADJ, 300 LB CAP |
| 00815067012749 - Probasics | 2024-05-22 Ascent Rollator, Rose Gold, HT ADJ, 300 LB CAP |
| 00815067012756 - Probasics | 2024-05-22 Ascent Rollator, Black, HT ADJ, 300 LB CAP |
| 00815067012763 - Probasics | 2024-05-01 K3 LITE WHEELCHAIR, 16X16 W/ SAFR, FLIP BACK HEIGHT ADJ DESK ARMS / CP: 1 |
| 00815067012770 - Probasics | 2024-05-01 K3 LITE WHEELCHAIR, 16X16 W/ ELR, FLIP BACK HEIGHT ADJ DESK ARMS / CP: 1 |
| 00815067012787 - Probasics | 2024-05-01 K3 LITE WHEELCHAIR, 18X16 W/ SAFR, FLIP BACK HEIGHT ADJ DESK ARMS / CP: 1 |
Trademark Results [Mountain Valley]
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