FDA.reportPublic FDA data

Lafayette Hand-Held Dynamometer

Primary DI
00855170007003
Brand
Lafayette Hand-Held Dynamometer
Company
LAFAYETTE INSTRUMENT COMPANY, INC.
Model
01165
Catalog number
01165
Device description
The Lafayette Hand-Held Dynamometer is an ergonomic hand-held device for objectively quantifying muscle strength. The device comes in an ergonomic plastic housing that fits comfortably in the palm of the hand. An elastic strap helps keep the HHD in place. The device has a LCD screen for data readout and menus for setup. The patient pushes on a stirrup accessory which is attached to the shaft of a force measuring load cell. The load cell senses the amount of force being applied to the device by the patient and this load is displayed in the LCD in pounds, kilograms or newtons. An optional test stand accessory and holder are used to position the HHD for the test.
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
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQXGoniometer, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855170007003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855170007003008551700070038551700070030855170007003

GMDN Terms#

Term, Definition table
TermDefinition
Back/leg/chest dynamometer, electronicA portable, hand-held, electrically-powered, digital instrument designed to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion. It includes a force gauge, which may be attached to a handle or strap, to assess force generated during a variety of movements (e.g., leg abduction, lifting) and/or force required to be exerted by a clinician to overcome a patient’s resistance (break test techniques). Is typically used to test or control a patient's muscle strength as part of a rehabilitation program.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature40 Degrees Fahrenheit95 Degrees Fahrenheit
Storage Environment Temperature40 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
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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