FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IKKSystem, Isokinetic Testing And Evaluation

Product Code Classifications

CodeDeviceSpecialtyClass
IKKSystem, Isokinetic Testing And EvaluationPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04595318292019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04595318292019045953182920194595318292019

GMDN Terms

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

Regulatory Flags

DUNS number
712811199
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B108660POMUS00R-GAITBTL INDUSTRIES LIMITEDIKK2026-03-19
09120077180250LEXOtyromotion GmbHIKK2026-03-12
06979351820015Upper Limb Rehabilitation Training SystemShanghai ZDROID Medical Technology Co.,Ltd.IKK2025-12-23
05061081950009LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03
05061081950184LifeGlov and Lifehub SystemBIOLIBERTY LTDIKK2025-12-03
00810188050021Bioness Integrated System (BITS) Bedside ConfigurationBioness Medical, Inc.IKK2025-07-18
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBioness Medical, Inc.IKK2025-07-18
00810188050038Bioness Integrated System (BITS) Mobile ConfigurationBioness Medical, Inc.IKK2025-07-17
08809209591980InBodyInBody Co., Ltd.IKK2025-05-09
00860013061104ReflexAssistive Technology Development, Inc.IKK2025-04-23
04041925006117PHS - XSmedica - Medizintechnik GmbHIKK2024-11-14
04041925006124PHS - Smedica - Medizintechnik GmbHIKK2024-11-14
04041925006131PHS - Mmedica - Medizintechnik GmbHIKK2024-11-14
04041925006148PHS - Lmedica - Medizintechnik GmbHIKK2024-11-14
04041925006155PHS - XLmedica - Medizintechnik GmbHIKK2024-11-14
00860002828749PortableConnectRom Technologies, Inc.IKK2024-03-20
00628719321003Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321010Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321027Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321034Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321041Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321058Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321065Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00628719321072Trexo RoboticsTrexo Robotics Inc.IKK2024-02-05
00840216113978PRIMOAsp Global, LLCIKK2023-11-15
08800101600183rebless (Model: RHDB)H ROBOTICS INC.IKK2023-10-30
04041925002775THERA-Trainer lyramedica - Medizintechnik GmbHIKK2023-10-23
07640174660353ArmeoHOCOMA AGIKK2023-10-11
07640174660377ManovoHOCOMA AGIKK2023-10-11
07640174660391ArmeoHOCOMA AGIKK2023-10-11