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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device percussor, powered-electric
Product CodeBYI
Regulation Number 868.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRPHYSIO PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
ELECTROMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM SERVICES PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
MED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 4 4
2018 9 9
2019 6 6
2020 4 4
2021 15 15
2022 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 27 27
Insufficient Information 9 9
Increase in Pressure 4 4
Smoking 4 4
Overheating of Device 3 3
Device Emits Odor 2 2
Pressure Problem 2 2
Sparking 2 2
Patient-Device Incompatibility 1 1
Noise, Audible 1 1
Crack 1 1
Electromagnetic Interference 1 1
Use of Device Problem 1 1
Vibration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 11 11
No Clinical Signs, Symptoms or Conditions 11 11
Pneumothorax 4 4
No Patient Involvement 3 3
Patient Problem/Medical Problem 3 3
No Consequences Or Impact To Patient 2 2
Vertebral Fracture 2 2
Insufficient Information 2 2
Stroke/CVA 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Easy Bruising 1 1
Hernia 1 1
Neck Pain 1 1
Spinal Column Injury 1 1
Hematoma 1 1
No Known Impact Or Consequence To Patient 1 1
No Code Available 1 1
Aspiration Pneumonitis 1 1
Cough 1 1
Respiratory Insufficiency 1 1
Unspecified Ear or Labyrinth Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 HILL-ROM MANUFACTURING, INC. II Nov-30-2017
2 Smiths Medical ASD Inc. II Apr-29-2021
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