Back 3 COLOR

GUDID 08800092020038

Daeyang Medical Co., Ltd.

Multi-modality physical therapy system
Primary Device ID08800092020038
NIH Device Record Key6a4c1252-c68a-4d56-8dba-8f76c5f67630
Commercial Distribution StatusIn Commercial Distribution
Brand NameBack 3 COLOR
Version Model Number2003
Company DUNS688463749
Company NameDaeyang Medical Co., Ltd.
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com
Phone+3367125150
Emailbwollensack@winback.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800092020038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBXMassager, Vacuum, Radio Frequency Induced Heat

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-04
Device Publish Date2023-04-26

Devices Manufactured by Daeyang Medical Co., Ltd.

08800092020038 - Back 3 COLOR2023-05-04
08800092020038 - Back 3 COLOR2023-05-04
08800092010855 - Winback Back 3SE2020-12-28

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