TENSAMAX PRO+

GUDID 08800092099010

Daeyang Medical Co., Ltd.

Multi-modality physical therapy system, professional-use

• Primary Device ID: 08800092099010
• NIH Device Record Key: 21b06a45-ca50-41fa-922d-5751dc94197f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TENSAMAX PRO+
• Version Model Number: 200C
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800092099010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214090

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: 2025-06-30
• Device Publish Date: 2025-06-20

Devices Manufactured by Daeyang Medical Co., Ltd.

• 08800092099010 - TENSAMAX PRO+: 2025-06-30
• 08800092099010 - TENSAMAX PRO+: 2025-06-30
• 08800092020038 - Back 3 COLOR: 2023-05-04
• 08800092010855 - Winback Back 3SE: 2020-12-28