Algomed Computerized Pressure Algometer

Basic Information

• Brand Name: Algomed Computerized Pressure Algometer
• Primary DI: 07290103039059
• Version / Model: FPIX
• Catalog Number: AS 00300
• Company Name: MEDOC LTD.
• Labeler DUNS: 600469191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: fae4801f-4b4c-47e4-a7ba-9e267895f75b

Device Description

The Algometer provides pain diagnostic testing with digital clarity and computer interface for data logging. The AlgoMed Computerized Pressure Algometry is an Algometry device including advanced software package designed for clinical use and advance research in the field of Pain Management. The AlgoMed enables the user to perform various pressure test paradigms including the method of limits and the ramp and hold method. These test paradigms can be utilized for a wide range of pressure pain measures such as pressure pain threshold and tolerance, temporal summation, DNIC and more. The device can also evaluate disease or treatment progress over time.

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
HRW	Dynamometer, Nonpowered	Orthopedic	888.1250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12950	Pressure algesimeter	A manual instrument designed to measure a patient's sensitivity to pain (pain threshold) by applying a painful, calibrated mechanical force to the skin. It typically consists of a sharp needle, a blunt tip, and a strain gauge; the pressure needed to feel the pain produced by the sharp point of the needle, as measured by the pressure exerted on an adjacent blunt tip in unaffected areas, is used to determine the pain threshold (15 grams is considered typical). The device 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	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07290103039554	GS1	Carton Box	1	In Commercial Distribution
Primary	07290103039059	GS1