FDA UDI
In Commercial Distribution
🇺🇸 United States
E-LINK Myo-EX GX3 EMG Sensor
DI: 05060481690102
·
Model: GX3
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BIOMETRICS LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- E-LINK Myo-EX GX3 EMG Sensor
- Primary DI
- 05060481690102
- Version / Model
- GX3
- Catalog Number
- GX3 plastic connector
- Company Name
- BIOMETRICS LIMITED
- Labeler DUNS
- 519969810
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-10
- Public Version
- 1
- Public Version Date
- 2018-09-10
- Public Version Status
- New
- Public Device Record Key
- fb7e75b0-ce24-49d7-85c7-877b0a3e79b8
Device Description
Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX3 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. Plastic connector for use with E-LINK X4 MkIV Interface Unit with plastic connectors. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| ISD | Exerciser, Measuring | Physical Medicine | 890.5360 | 2 |
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63313 | Kinesiology/electromyographic sensor set | A collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. It is typically intended to be used with a computer, interface devices, and software (not included). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060481690102 | GS1 |