FDA.reportPublic FDA data

microfet2

Primary DI
00850002429008
Brand
microfet2
Company
Hoggan Scientific L.L.C.
Model
5021
Device description
microFET®2 is a hand-held dynamometer (HHD) for performing muscle tests to quantitatively measure muscle weakness caused by injury, as well as measure general muscle strength. The device is used to convey an individual’s ability to resist force for a specific muscle or muscle group being tested.
Published
2025-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LBBDynamometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBBDynamometer, Ac-PoweredOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162412000Hoggan Scientific® microFET2™Hoggan Scientific, LLC2017-03-09LBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002429008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002429008008500024290088500024290080850002429008

GMDN Terms#

Term, Definition table
TermDefinition
Dynamometer force gaugeAn electrically-powered component of a digital (electric) dynamometer intended to measure and display and/or communicate forces during assessment of neuromuscular function. It is a small unit with a built-in force sensor and is intended to be used with an appropriate dynamometer attachment(s); it is not a complete dynamometer. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078431102
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002429114microfet handgrip5050-1002025-02-25
00850002429190microFET Pinch50802025-02-25
00850002429312microfet350262025-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809513720298SAEHAN Digital Hand Dynamometer(DHD-1)Saehan CorporationLBB2026-05-18
08809513720373SAEHAN Digital Hand Dynamometer(DHD-3)Saehan CorporationLBB2026-05-18
00850004866184ActivForce 2ActivBody, Inc.LBB2025-09-03
05430004547006EfortoUniwebLBB2025-03-07
00850002429114microfet handgripHoggan Scientific L.L.C.LBB2025-02-25
00850002429190microFET PinchHoggan Scientific L.L.C.LBB2025-02-25
00850002429312microfet3Hoggan Scientific L.L.C.LBB2025-02-24
03770011995370KForce Muscle ControllerKINVENT BIOMECANIQUELBB2024-01-03
03770011995424KForce LinkKINVENT BIOMECANIQUELBB2024-01-03
03770011995431KForce GripKINVENT BIOMECANIQUELBB2024-01-03
03770011995455KForce BubbleKINVENT BIOMECANIQUELBB2024-01-03
D091INNOCP030Innobyte Bilateral Clinical PackageKube Innovation IncLBB2023-06-26
D091INNOMP030Innobyte Bilateral Mouthpiece ReplacementKube Innovation IncLBB2023-06-26
D091INNOCA010Innobyte Clinical PackageKube Innovation IncLBB2022-01-11
D091INNOMP010Innobyte Full-Arch Mouthpiece SensorKube Innovation IncLBB2022-01-11
03770011995004KINVENTKINVENT HELLASLBB2020-08-01
03770011995103KINVENTKINVENT HELLASLBB2020-08-01
03770011995332KINVENTKINVENT HELLASLBB2020-08-01
03770011995448KINVENTKINVENT HELLASLBB2020-08-01
B824SR3053M1SR-3053RED OAK INSTRUMENTS, LLCLBB2020-01-10
B824SR3053S1SR-3053RED OAK INSTRUMENTS, LLCLBB2020-01-10
10850828007012AcroGrip™ DeviceAXOGEN CORPORATIONLBB2017-05-15
10850828007029AcroPinch™ DeviceAXOGEN CORPORATIONLBB2017-05-15