FDA UDI
In Commercial Distribution
🇺🇸 United States
Winner EVO Combo
DI: 00853904006193
·
Model: 400-079
·
COMPASS HEALTH BRANDS CORP.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Winner EVO Combo
- Primary DI
- 00853904006193
- Version / Model
- 400-079
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-21
- Public Version
- 3
- Public Version Date
- 2023-08-21
- Public Version Status
- Update
- Public Device Record Key
- 0811f36f-cb56-4174-9503-e461633d7a1e
Device Description
Winner CM2P-portable 2 channel combo in a hard carry case
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LIH | Interferential Current Therapy | Neurology | 882.5890 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | Physical Medicine | 890.5860 | 2 |
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | Physical Medicine | 890.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17908 | Physical therapy ultrasound/neuromuscular stimulation system | An assembly of devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853904006193 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013771 | 000 |