TEC.BEAN

GUDID 06971712727452

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712727452
• NIH Device Record Key: 47cdb1bb-501f-4727-adf5-96292132f96b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEC.BEAN
• Version Model Number: SM9910
• Company DUNS: 421286946
• Company Name: Hong Qiangxing (Shen Zhen) Electronics Limited
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971712727452 [Primary]
GS1	16971712727459 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233092

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

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: 2024-12-10
• Device Publish Date: 2024-12-02

Devices Manufactured by Hong Qiangxing (Shen Zhen) Electronics Limited

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• 16971712724748 - Techcare: 2025-05-22 Touch X
• 16971712724786 - Unimed: 2025-05-22 Pro X
• 16971712726087 - Nuemedics: 2025-05-22 BLACK
• 16971712726100 - Nuemedics: 2025-05-22 BLACK COMBO SET
• 16971712720276 - Techcare: 2025-05-21 BLACK
• 16971712724724 - Techcare: 2025-05-21 BLACK COMBO SET
• 16971712725509 - Techcare: 2025-05-21 RED