| Primary Device ID | 05060481690010 |
| NIH Device Record Key | b8700fd1-f0d8-45a9-bc16-7905602dfe7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | E-LINK Upper Limb Exerciser |
| Version Model Number | E4000 |
| Company DUNS | 519969810 |
| Company Name | BIOMETRICS LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060481690010 [Primary] |
| ION | Exerciser, Non-Measuring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-11 |
| Device Publish Date | 2018-02-14 |
| 05060481691666 - DataLOG MWX8 | 2020-03-05 The DataLOG is the latest in data acquisition technology developed to meet the needs of researchers for portable data collection |
| 05060481691673 - DataLOG Management Software (Version 10) | 2020-03-05 The DataLOG Management Software allows the user to set up the DataLOG communications with the computer, configure the sensors, c |
| 05060481691680 - DataLOG Management + Analysis Software (Version 10) | 2020-03-05 The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time |
| 05060481691789 - DataLOG MWX8 | 2020-03-05 The DataLOG is the latest in data acquisition technology developed to meet the needs of researchers for portable data collection |
| 05060481690102 - E-LINK Myo-EX GX3 EMG Sensor | 2018-09-10 Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of volu |
| 05060481690119 - E-LINK Myo-EX GX4 EMG Sensor | 2018-09-10 Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of volu |
| 05060481690157 - E-LINK Myo-EX GX5 Wireless EMG Sensor | 2018-09-10 Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of volu |
| 05060481690195 - E-LINK DG1 Wireless Dongle | 2018-09-10 The wireless Dongle (DG1) enables E-LINK to be used as a complete stand-alone wireless evaluation and exercise system.This produ |