AccessGUDID - DEVICE: Algomed Computerized Pressure Algometer (07290103039059)

GUDID

Device Identifier (DI) Information

Brand Name: Algomed Computerized Pressure Algometer
Version or Model: FPIX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS 00300
Company Name: MEDOC LTD.

Primary DI Number: 07290103039059
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600469191 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HRW	Dynamometer, Nonpowered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fae4801f-4b4c-47e4-a7ba-9e267895f75b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016