FDA UDI
In Commercial Distribution
🇺🇸 United States
Echo Algometer
DI: G0419RF3070
·
Model: 9RF307
·
JTECH Medical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Echo Algometer
- Primary DI
- G0419RF3070
- Version / Model
- 9RF307
- Company Name
- JTECH Medical
- Labeler DUNS
- 625089131
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-14
- Public Version
- 1
- Public Version Date
- 2021-05-24
- Public Version Status
- New
- Public Device Record Key
- 5e46fa0e-c872-46f2-8927-4c8275f08aa6
Device Description
A device to assist the clinician with establishing an objective assessment of a person’s pressure threshold and pain tolerance. The device is intended to be non-invasive, non-surgical and transient.
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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HRW | Dynamometer, Nonpowered | Orthopedic | 888.1250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63452 | Pressure algometer, electronic | A hand-held, electronic instrument designed to measure a patient's sensitivity to pain (pain threshold) through manual application of a measured mechanical force to the skin. It typically consists of a patient-contact tip, and a strain gauge where results are displayed digitally. Also referred to as a pressure algesimeter or algesiometer, it is typically used to evaluate the effects of pain after the use of analgesics and/or during diagnosis or treatment of nerve injuries and neuropathies. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G0419RF3070 | HIBCC |
Customer Contacts
- Phone
- 385-695-5000
- [email protected]