FDA.reportPublic FDA data

SR-3053

Primary DI
B824SR3053S1
Brand
SR-3053
Company
RED OAK INSTRUMENTS, LLC
Model
S
Catalog number
SR-3053-S
Device description
Fine motor control measurements
Published
2020-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K012492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012492000KADANCE 2000Kada Research, Inc.2001-11-02LBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B824SR3053S1PrimaryHIBCC0

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
9999999999support@redoakinstruments.com

Regulatory Flags#

DUNS number
025026245
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B824SR3053M1SR-3053MSR-3053-M2020-01-10

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
10850828007012AcroGrip™ DeviceAXOGEN CORPORATIONLBB2017-05-15
10850828007029AcroPinch™ DeviceAXOGEN CORPORATIONLBB2017-05-15