Identity
- Trade Name
- Northstar Echo Algometer FDA UDI
- Generic Name
- Pressure algometer, electronic FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 9RF407 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G0419RF4070 FDA UDI
- FDA Product Code
- HRW FDA UDI
- GMDN Term
- Pressure algometer, electronic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pressure algometer, electronic
Northstar Echo Algometer by J-Tech Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pressure algometer, electronic.
- Echo Algometer — J-Tech Medical, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- J-Tech Medical, Inc.
Sources (1)
- FDA UDI 718e0c9c-8dd7-41f3-9827-900391e7ebfb 34 fields · synced May 30, 2026