FDA UDI
In Commercial Distribution
🇺🇸 United States
Ibramed
DI: 07898961579030
·
Model: NEUROTONUS PORTABLE TENS FES
·
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ibramed
- Primary DI
- 07898961579030
- Version / Model
- NEUROTONUS PORTABLE TENS FES
- Catalog Number
- 01002025
- 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
- 19993e96-fd35-49b9-a711-87191108ec36
Device Description
NEUROTONUS PORTABLE TENS FES transcutaneous neuromuscular stimulator is a two-channel stimulator with independent controls for current therapies used in: TENS (Transcutaneous Electrical Nerve Stimulation) and FES (Functional Electrical Stimulation).
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 |
|---|---|---|---|---|
| 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 | 07898961579030 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131923 | 000 |