FDA UDI
In Commercial Distribution
🇺🇸 United States
DataLITE LE230 Wireless EMG Sensor
DI: 05060481690638
·
Model: LE230
·
BIOMETRICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DataLITE LE230 Wireless EMG Sensor
- Primary DI
- 05060481690638
- Version / Model
- LE230
- Company Name
- BIOMETRICS LIMITED
- Labeler DUNS
- 519969810
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-09
- Public Version
- 1
- Public Version Date
- 2018-09-10
- Public Version Status
- New
- Public Device Record Key
- 7fced320-417b-4153-a702-7d4fabacbbcf
Device Description
The DataLITE wireless surface EMG sensor gives superb quality of signal and ease of use. With a bandwidth of 5-495 Hz and a built in 1000 gain amplifier and wireless transmitter, surface EMG signals are collected and sent to the Biometrics software for analysis. EMG data can be synchronized real-time with other sensors as part of a complete DataLITE system.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
- 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 |
|---|---|---|---|---|
| HCC | Device, Biofeedback | Neurology | 882.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38443 | Electromyography telemetric monitoring system transmitter | A body-worn, battery-powered component of an electromyography telemetric monitoring system designed to continuously measure and wirelessly transmit electromyographic (EMG) signals to the system's receiver. The transmitter typically includes an antenna and attached sensors (e.g., lead wires and electrodes) that are connected to the patient. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060481690638 | GS1 |