FDA.reportPublic FDA data

Algomed Computerized Pressure Algometer

Primary DI
07290103039554
Brand
Algomed Computerized Pressure Algometer
Company
MEDOC LTD.
Model
FPIX
Catalog number
AS 00300
Device description
The Algometer provides pain diagnostic testing with digital clarity and computer interface for data logging. The AlgoMed Computerized Pressure Algome
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HRWDynamometer, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRWDynamometer, NonpoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290103039554PackageGS11In Commercial Distribution
07290103039059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290103039554072901030395547290103039554
07290103039059072901030390597290103039059

GMDN Terms#

Term, Definition table
TermDefinition
Pressure algesimeterA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600469191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290103039011Medoc Main Station SoftwareMMSSW 000122023-06-20
07290103039066CoVasCoVasAS 002132023-06-20
07290103039073One Button Response UnitOBRUDT 000122023-06-20
07290103039219 Thermode CHEPSTSA 2AS 004202023-06-20
07290103039233Q-Sense Response UnitQ-SenseAS 004032023-06-20
07290103039240Q-Sense Base AssemblyQ-SenseAS 004002023-06-20
07290103039264Patient Response UnitPRUAS 002432023-06-20
07290103039653VSA 2 Hand HeldVSA 2MO 000172023-06-20
07290103039660VSA 2 Handheld deviceVSA 2 Handheld DeviceAS 004222023-06-20
07290103039677VSA 2 Hand-Leg supportVSA 2 Leg AS 004252023-06-20
07290103039820TSA 2 Air TSA 2 Air 2023-06-20
07290103039837TSA 2 Air TSA 2 Air AS 001892023-06-20
07290103039899TSA 2TSA 2AS 001702023-06-20
07290103039905TSA 2TSA 2MO 000152023-06-20
07290103039912Thermode 30X30 (TSA 2) TSA 2 30X30AS 001762023-06-20
07290103039929Thermode 16X16 (TSA 2) Thermode 16X16AS 001772023-06-20
07290103039936Thermode fMRI 30*30mm - including fMRI filterThermode fMRIAS 001782023-06-20
07290103039943Thermode fMRI 16X16mm - including fMRI filterfMRI ThermodeAS 001792023-06-20
07290103039950Thermode CHEPS fMRI CHEPSAS 004212023-06-20
07290103039967Thermode 6mm diameterTSA 2AS 001852023-06-20

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