FDA.reportPublic FDA data

Mintal Tracker

Primary DI
04595318292019
Brand
Mintal Tracker
Company
HICLUB, INC.
Model
/
Published
2023-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IKKSystem, Isokinetic Testing And Evaluation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKKSystem, Isokinetic Testing And EvaluationPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04595318292019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04595318292019045953182920194595318292019

GMDN Terms#

Term, Definition table
TermDefinition
Sleep disorder interpretive software, patient-useAn interpretive software program intended to be installed on an off-the-shelf smartphone/tablet for use by a patient/layperson in the home to record and analyse patient physiological data collected during sleep using a home-use device (e.g., CPAP/BPAP unit therapy analyser, microphone), for self-analysis of sleep/sleep therapy. It may be used to assist a patient to refine their sleep therapy, or to better understand their sleep behaviour, and might in addition be intended to assist a healthcare professional to treat/understand a sleep disorder.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
712811199
Device count
1
Premarket exempt
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010525609Proprio SystemsPerry Dynamics, Inc.IKK2026-07-29
00860010525616Proprio SystemsPerry Dynamics, Inc.IKK2026-07-28
06978410840063FourierFourier Intelligence Inc.IKK2026-07-16
06978410840070FourierFourier Intelligence Inc.IKK2026-07-16
06978410840087FourierFourier Intelligence Inc.IKK2026-07-16
06975343590362Deweighting SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-07-10
06975343590379Deweighting SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-07-10
06975343590010Upper Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590027Lower Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590034Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590041Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590058Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590065Multi-joint isokinetic training and testing systemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590072Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590089Upper Limbs Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590133Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590140Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590157Upper Limbs Intelligent Feedback and Training SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590171Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590188Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590195Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590201Lower extremity intelligent feedback training system for childrenGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590218Gait Training and Evaluation SystemGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590225Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590256Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590287Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
06975343590300Upper and lower limb active and passive motion assessment training instrumentGuangzhou Yikang Medical Equipment Industrial Co.,LtdIKK2026-05-14
04041925006339PHS - XSmedica - Medizintechnik GmbHIKK2026-05-13
04041925006346PHS - Smedica - Medizintechnik GmbHIKK2026-05-13
04041925006353PHS - Mmedica - Medizintechnik GmbHIKK2026-05-13