Mountain Valley
GUDID 80092237618864
Ultra Cure Pro PLUS
COMPASS HEALTH BRANDS CORP.
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.
| 00092237616642 - Richmar | 2025-08-28 EMS 5.0 - Analog EMS |
| 00092237621974 - TwinStim | 2025-08-25 Twin Stim OTC Amazon |
| 00815067071227 - Probasics | 2025-08-22 Heavy Duty Quad Cane, Small Base Black |
| 00815067071234 - Probasics | 2025-08-22 Heavy Duty Quad Cane, Large Base, Black |
| 00815067013548 - Probasics | 2025-08-21 Adjustable Tension Back 16" |
| 00815067013555 - Probasics | 2025-08-21 Adjustable Tension Back 18" |
| 00815067013562 - Probasics | 2025-08-21 Adjustable Tension Back 20" |
| 00815067013579 - Probasics | 2025-08-21 Adjustable Tension Back 22" |
Trademark Results [Mountain Valley]
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