FDA.reportPublic FDA data

DualGrip Digital Grip Dynamometer

Primary DI
00855170007423
Brand
DualGrip Digital Grip Dynamometer
Company
LAFAYETTE INSTRUMENT COMPANY, INC.
Model
5030DG
Catalog number
5030DG
Device description
The DualGrip Digital Grip Dynamometer is grip strength measuring instrument. It is designed for routine assessment of the grip strength of a patient or can also be used in the evaluation of hand trauma or disease. As the patient grips the device, a load cell measures the applied force. An LCD readout indicates the force in pounds (lbs) or kilogram force (kgf). The grip dynamometer also features an adjustable handle that can accommodate two different grip positions. The DualGrip is designed to be easily held by adults and children with a focus on increased accuracy in the lower range.
Published
2024-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00855170007423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855170007423008551700074238551700074230855170007423

GMDN Terms#

Term, Definition table
TermDefinition
Hand dynamometer/pinchmeter, electronicAn electrically-powered instrument designed to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. It is used to assess a patient's grip strength in clinical or research settings, typically as part of a rehabilitation program for geriatric patients or those who have suffered a stroke; it may in addition be designed to be used as part of an interactive rehabilitation system whereby forces applied by the patient translate to movements in a video-game. It includes a force transducer to translate force into electrical impulses for measurement.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
765-423-1505bbrown@lafayetteinstrument.com

Regulatory Flags#

DUNS number
005080650
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855170007447Pneumograph - Non-Metallic 98in. Tubing76513NM98C76513NM98C2025-08-14
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00855170007416ROMI Dual Inclinometer SystemACU100-DUALACU100-DUAL2024-02-09
0085517000738670cm Long Arm Anthropometer01290A01290A2023-06-13
0085517000739330cm Short Arm Anthropometer01291A01291A2023-06-13
00855170007140PNEUMO NONMETALIC 10' LATEX FREE76513NM10A76513NM10A2023-06-12
00855170007157PED NONMETAL PNEUMO 10' LATEX FREE76513NM10P76513NM10P2023-06-12
00855170007164NONMETAL PNEUMO 12' LUER LATEX FREE76513NM12M 76513NM12M 2023-06-12
00855170007195"PNEUMO NONMETALIC 89"" LATEX FREE"76513NM89A 76513NM89A 2023-06-12
00855170007201"PED NONMETAL PNEUMO 89"" LATEX FREE"76513NM89P 76513NM89P 2023-06-12
00855170007034Large Bone Caliper01293012932021-08-31
00855170007041Small Bone Caliper01294012942021-08-31
00855170007232Chest Depth Caliper01140 01140 2021-08-31
00855170007256Abdominal Caliper01296012962021-08-31
00855170007379Lafayette Hand-Held Dynamometer01165A01165A2022-04-28
00855170007003Lafayette Hand-Held Dynamometer01165011652021-08-31
00855170007010Lafayette Skinfold Caliper01128011282021-08-31
00855170007027Lafayette Extendable Goniometer01135011352021-08-31
00855170007119Professional Hand Evaluation Kit5030K15030K12021-08-31
00855170007126Lafayette Professional Grip Dynamometer5030L15030L12021-08-31

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Primary DI, Brand, Company table
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00855170007119Professional Hand Evaluation KitLAFAYETTE INSTRUMENT COMPANY, INC.HRW2021-08-31