FDA.reportPublic FDA data

Lafayette Professional Grip Dynamometer

Primary DI
00855170007126
Brand
Lafayette Professional Grip Dynamometer
Company
LAFAYETTE INSTRUMENT COMPANY, INC.
Model
5030L1
Catalog number
5030L1
Device description
The Lafayette Grip or Pinch Dynamometers are hydraulic strength measuring instruments. They are designed for routine assessment of the grip and/or pinch strength of a patient or can also be used in the evaluation of hand trauma or disease. As the patient either grips or pinches the device, a column of hydraulic fluid activates a pressure gauge mounted on the top of the device. The gauge indicates the pinch or grip force in pounds (lbs) or kilogram force (kgf). A peak needle shows the maximum force applied during a single test. The peak needle is manually reset at the end of the test and peak values are recorded manually. The grip dynamometers also feature an adjustable handle that can accommodate five different grip positions.
Published
2021-08-31
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
00855170007126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855170007126008551700071268551700071260855170007126

GMDN Terms#

Term, Definition table
TermDefinition
Hand dynamometer/pinchmeter, mechanicalA non-powered, mechanical 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 and/or pinch strength in clinical or research settings, typically as part of a rehabilitation program for geriatric patients or those who have suffered a stroke. This device is commonly known as a Vigorimeter. It typically consists of various size squeeze bulbs and an analogue manometer to record the exerted effort. The patient will typically be asked to perform the test a few times so that the physician can obtain a mean value.

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
00855170007423DualGrip Digital Grip Dynamometer5030DG5030DG2024-09-11
00855170007409Lafayette Range of Motion InclinometerACU100ACU1002024-02-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809513720038SAEHAN Hydraulic Hand DynamometerSaehan CorporationHRW2026-05-18
08809513720052SAEHAN Squeeze DynamometerSaehan CorporationHRW2026-05-18
08809513720076Spring Hand DynamometerSaehan CorporationHRW2026-05-18
08809513720380Back-Leg-Chest DynamometerSaehan CorporationHRW2026-05-18
04719846012660CharderCHARDER ELECTRONIC CO., LTD.HRW2026-04-29
04719846017030CharderCHARDER ELECTRONIC CO., LTD.HRW2026-02-11
14719846017037CharderCHARDER ELECTRONIC CO., LTD.HRW2026-02-11
08033390301848General InstrumentLIMACORPORATE SPAHRW2025-06-10
08033390301855General InstrumentLIMACORPORATE SPAHRW2025-06-10
08033390301862General InstrumentLIMACORPORATE SPAHRW2025-06-10
08033390301879General InstrumentLIMACORPORATE SPAHRW2025-06-10
00855170007423DualGrip Digital Grip DynamometerLAFAYETTE INSTRUMENT COMPANY, INC.HRW2024-09-11
07290103039073One Button Response UnitMEDOC LTD.HRW2023-06-20
08033390237734PRIMA TT GlenoidLIMACORPORATE SPAHRW2022-12-03
08033390237741PRIMA TT GlenoidLIMACORPORATE SPAHRW2022-12-03
08033390109499NALIMACORPORATE SPAHRW2022-09-08
08033390196123NALIMACORPORATE SPAHRW2022-09-08
00840216112728JAMARAsp Global, LLCHRW2022-08-09
00840216112735JAMARAsp Global, LLCHRW2022-08-09
00840216112704JAMARAsp Global, LLCHRW2022-04-27
00840216112667JAMARAsp Global, LLCHRW2022-04-04
00840216112650JAMARAsp Global, LLCHRW2022-03-18
00840216112674JAMARAsp Global, LLCHRW2022-03-18
00840216112681JAMARAsp Global, LLCHRW2022-03-18
00840216112698JAMARAsp Global, LLCHRW2022-03-18
00840216112711JAMARAsp Global, LLCHRW2022-03-18
00840216112742JAMARAsp Global, LLCHRW2022-03-18
00840216112759JAMARAsp Global, LLCHRW2022-03-18
00840216112766JAMARAsp Global, LLCHRW2022-03-18
00840216112773JAMARAsp Global, LLCHRW2022-03-18