Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device recorder, magnetic tape, medical
Regulation Description Medical magnetic tape recorder.
Product CodeDSH
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
AEVICE HEALTH PTE. , LTD.
  SUBSTANTIALLY EQUIVALENT 2
ATSENS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BARDY DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
BIOTRICITY
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL INSTRUMENTATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
ICENTIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
LIFELENS TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEZOO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
QARDIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K201644  QardioCore
QUANTA COMPUTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOMNOMEDICS GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRADOS LABS
  SUBSTANTIALLY EQUIVALENT 1
STRADOS LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITALOGRAPH , LTD.
  SUBSTANTIALLY EQUIVALENT 1
WEARLINQ, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELLYSIS CORP.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 76 76
2020 91 91
2021 113 114
2022 46 46
2023 65 66
2024 88 88
2025 215 215

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 284 284
Use of Device Problem 284 284
Adverse Event Without Identified Device or Use Problem 39 39
Patient Data Problem 37 37
Patient Device Interaction Problem 7 7
Improper or Incorrect Procedure or Method 7 7
Output Problem 4 4
Loss of or Failure to Bond 4 4
Insufficient Information 3 3
Biocompatibility 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Handling Problem 2 2
Product Quality Problem 2 3
Appropriate Term/Code Not Available 2 2
Overheating of Device 2 2
Failure to Charge 1 1
Device Slipped 1 1
Reset Problem 1 2
False Negative Result 1 1
Restricted Flow rate 1 1
Unintended Electrical Shock 1 1
Wrong Label 1 1
Failure to Transmit Record 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Moisture Damage 1 1
Unable to Obtain Readings 1 1
Missing Test Results 1 1
Misconnection 1 1
No Apparent Adverse Event 1 1
Missing Information 1 1
Electromagnetic Interference 1 1
Loose or Intermittent Connection 1 1
Loss of Data 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Inflammation/ Irritation 320 320
Skin Irritation 122 122
Hypersensitivity/Allergic reaction 111 111
Skin Infection 55 55
No Clinical Signs, Symptoms or Conditions 36 37
Contact Dermatitis 35 35
Blister 23 23
Itching Sensation 19 19
Skin Burning Sensation 14 14
Insufficient Information 14 15
Erythema 14 14
Anaphylactoid 14 14
Unspecified Heart Problem 13 13
Rash 12 12
Unspecified Tissue Injury 6 6
Scar Tissue 6 6
Cellulitis 5 5
Skin Discoloration 5 5
Burn(s) 5 5
Fluid Discharge 5 5
Arrhythmia 5 5
No Code Available 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Skin Tears 4 4
Superficial (First Degree) Burn 4 4
Hemorrhage/Bleeding 4 4
Bruise/Contusion 4 4
Burning Sensation 3 3
Swelling/ Edema 3 3
Urticaria 3 3
Local Reaction 2 2
No Known Impact Or Consequence To Patient 2 2
Dyspnea 2 2
Pain 2 2
Tachycardia 2 2
No Consequences Or Impact To Patient 2 2
Ventricle, Abnormality Of 1 1
Blood Loss 1 1
Skin Disorders 1 1
Inflammation 1 1
Dizziness 1 1
Discomfort 1 1
Depression 1 1
Nausea 1 1
Reaction 1 1
Anaphylactic Shock 1 1
Anxiety 1 1
Caustic/Chemical Burns 1 1
Loss of consciousness 1 1
Heart Block 1 1

-
-