FDA UDI
In Commercial Distribution
🇺🇸 United States
Ibramed
DI: 07898961579108
·
Model: NEUROTONUS MULTIWAVE
·
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ibramed
- Primary DI
- 07898961579108
- Version / Model
- NEUROTONUS MULTIWAVE
- Catalog Number
- 01002023
- Company Name
- Ibramed Industria Brasileira de Equipamentos Medicos Eir
- Labeler DUNS
- 903359565
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 03f7633d-1255-4199-91e4-83fb15cb063d
Device Description
NEUROTONUS MULTIWAVE transcutaneous neuromuscular stimulator is a four-channel stimulator with independente controls for current therapies used in: TENS (Transcutaneous Electrical Nerve Stimulation), FES (Functional Electrical Stimulation); RUSSIAN CURRENT (Burst Modulated Medium Frequency), AUSSIE CURRENT (Burst Modulated Medium Frequency), INTERFERENTIAL CURRENT (Amplitude Modulated Medium Frequency), DIRECT CURRENT/POLARIZED CURRENT or MICROCURRENT.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
| GZI | Stimulator, Neuromuscular, External Functional | Neurology | 882.5810 | 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 | 07898961579108 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131629 | 000 |