Winback Back 3SE

GUDID 08800092010855

Daeyang Medical Co., Ltd.

Multi-modality physical therapy system

• Primary Device ID: 08800092010855
• NIH Device Record Key: 1b877339-8348-4ce4-951a-29a243948ba8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Winback Back 3SE
• Version Model Number: 1085
• Company DUNS: 688463749
• Company Name: Daeyang Medical 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team
• Phone: +330483661666
• Email: llanier@swims.team

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800092010855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162828

FDA Product Code

• PBX: Massager, Vacuum, Radio Frequency Induced Heat

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: 2020-12-28
• Device Publish Date: 2020-12-18

Devices Manufactured by Daeyang Medical Co., Ltd.

• 08800092020038 - Back 3 COLOR: 2023-05-04
• 08800092010855 - Winback Back 3SE: 2020-12-28
• 08800092010855 - Winback Back 3SE: 2020-12-28