POWER-Q1000PLUS

GUDID 08809277420885

Sequential venous compression system pump, A power inflatable tube massager

WONJIN MULSAN CO.LTD

Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump Sequential venous compression system pump

• Primary Device ID: 08809277420885
• NIH Device Record Key: 65bdf601-0669-444c-95a6-a470329be067
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWER-Q1000PLUS
• Version Model Number: WHF-324
• Company DUNS: 690287912
• Company Name: WONJIN MULSAN CO.LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-646-797-4200
• Email: wonjin@wonjininc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809277420885 [Primary]
GS1	18809277420882 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	28809277420889 [Package]; Contains: 18809277420882; Package: [2 Units]; In Commercial Distribution
GS1	38809277420886 [Package]; Contains: 18809277420882; Package: [4 Units]; In Commercial Distribution
GS1	48809277420883 [Package]; Contains: 18809277420882; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100656

FDA Product Code

• IRP: Massager, Powered Inflatable Tube

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-25
• Device Publish Date: 2019-04-17

Devices Manufactured by WONJIN MULSAN CO.LTD

• 18809277423470 - WONJIN: 2022-01-19 Sequential venous compressiion system pump, a power inflatable tube massager
• 08809277420014 - POWER-Q1000: 2022-01-04 Sequential venous compression system pump, A powered inflatable tube massager
• 38809277423214 - EXTENSION ZIPPER: 2020-01-21 EXTENSION ZIPPER for POWER Q1000 PREMIUM
• 18809277421674 - SINGLE HOSE: 2019-07-23 SINGLE HOSE for POWER-Q1000 PLUS
• 08809277420885 - POWER-Q1000PLUS: 2019-04-25Sequential venous compression system pump, A power inflatable tube massager
• 08809277420885 - POWER-Q1000PLUS: 2019-04-25 Sequential venous compression system pump, A power inflatable tube massager
• 38809277420442 - POWER-Q1000PREMIUM: 2018-07-06 Sequential venous compression system pump, A powered inflatable tube massager
• 48809277426021 - POWER-Q1000: 2018-07-06 Sequential venous compression system pump, A powered inflatable tube massager