| Primary Device ID | G0419RF4060 |
| NIH Device Record Key | cc5f79a8-5679-4586-991a-837ea90c88db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Northstar Echo Grip Gauge |
| Version Model Number | 9RF406 |
| Company DUNS | 625089131 |
| Company Name | JTECH Medical |
| 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 | false |
| 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 | false |
| Phone | 385-695-5000 |
| support@jtechmedical.com | |
| Phone | 385-695-5000 |
| support@jtechmedical.com | |
| Phone | 385-695-5000 |
| support@jtechmedical.com | |
| Phone | 385-695-5000 |
| support@jtechmedical.com | |
| Phone | 385-695-5000 |
| support@jtechmedical.com | |
| Phone | 385-695-5000 |
| support@jtechmedical.com | |
| Phone | 385-695-5000 |
| support@jtechmedical.com | |
| Phone | 385-695-5000 |
| support@jtechmedical.com | |
| Phone | 385-695-5000 |
| support@jtechmedical.com | |
| Phone | 385-695-5000 |
| support@jtechmedical.com | |
| Phone | 385-695-5000 |
| support@jtechmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G0419RF4060 [Primary] |
| HRW | Dynamometer, Nonpowered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-24 |
| Device Publish Date | 2021-05-14 |
| G0419CM1130 - Dualer IQ Pro Primary Inclinometer | 2021-05-24 A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is inte |
| G0419CM1140 - Dualer IQ Pro Secondary Inclinometer | 2021-05-24 A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is inte |
| G0419RF3030 - Echo Primary Inclinometer | 2021-05-24 A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is inte |
| G0419RF3040 - Echo Secondary Inclinometer | 2021-05-24 A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is inte |
| G0419RF3050 - Echo Muscle Tester | 2021-05-24 A device to assist the clinician with establishing an objective assessment of a person’s physical strength. The device is inte |
| G0419RF3060 - Echo Grip Gauge | 2021-05-24 A device to assist the clinician with establishing an objective assessment of a person’s physical strength. The device is inte |
| G0419RF3070 - Echo Algometer | 2021-05-24 A device to assist the clinician with establishing an objective assessment of a person’s pressure threshold and pain tolerance |
| G0419RF3080 - Echo Goniometer | 2021-05-24 A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is inte |