FDA.reportPublic FDA data

AcroPinch™ Device

Primary DI
10850828007029
Brand
AcroPinch™ Device
Company
AXOGEN CORPORATION
Model
EN-248
Device description
Hand dynamometer intended for use with the AcroVal™ Neurosensory & Motor Testing System (NSMTS) to measure the pinch force of a patient’s fingers.
Published
2017-05-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBBDynamometer, Ac-Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850828007029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085082800702910850828007029

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888.296.4361CustomerCare@AxoGenInc.com

Regulatory Flags#

DUNS number
113424464
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850828007012AcroGrip™ DeviceEN-2472017-05-15
10850828007036AxoTouch™ Two-Point Discriminator2PDGA12017-05-15
00850828007107Axoguard HA+ Nerve ProtectorAGHA122023-04-24
00850828007114Axoguard HA+ Nerve ProtectorAGHA222023-04-24
00850828007121Axoguard HA+ Nerve ProtectorAGHA242023-04-24
00850828007138Axoguard HA+ Nerve ProtectorAGHA362023-04-24
00850828007145Axoguard HA+ Nerve ProtectorAGHA482023-04-24
00850828007046AxoGuard Nerve CapAGT2152017-10-24
00850828007053AxoGuard NerveCapAGT3152017-10-24
00850828007060AxoGuard Nerve CapAGT4152017-10-24
00850828007077AxoGuard Nerve CapAGT5202017-10-24
00850828007084AxoGuard Nerve CapAGT6202017-10-24
00850828007091AxoGuard Nerve CapAGT7202017-10-24
10850828007104Axoguard HA+ Nerve ProtectorAGHA122023-04-24
10850828007111Axoguard HA+ Nerve ProtectorAGHA222023-04-24
10850828007128Axoguard HA+ Nerve ProtectorAGHA242023-04-24
10850828007135Axoguard HA+ Nerve ProtectorAGHA362023-04-24
10850828007142Axoguard HA+ Nerve ProtectorAGHA482023-04-24

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
00850002429008microfet2Hoggan Scientific L.L.C.LBB2025-02-21
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