PUREHEAL Overlapped Compression Therapy

GUDID 06976331789102

Joicom Corporation

Circulating-fluid thermal/compression therapy system wrap
Primary Device ID06976331789102
NIH Device Record Key961d5b74-a5d9-40d8-a7f7-c0630352ee28
Commercial Distribution StatusIn Commercial Distribution
Brand NamePUREHEAL Overlapped Compression Therapy
Version Model NumberPH-F01
Company DUNS033774836
Company NameJoicom Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106976331789102 [Primary]
GS116976331789109 [Package]
Package: [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IRPMassager, Powered Inflatable Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-16
Device Publish Date2023-05-08

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