FIT BELT

GUDID 06971712726363

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712726363
• NIH Device Record Key: b801c2b1-3b80-49eb-b60f-9aaba997f626
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIT BELT
• Version Model Number: SM9023
• Company DUNS: 421286946
• Company Name: Hong Qiangxing (Shen Zhen) Electronics Limited
• Device Count: 36
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	06971712726363 [Unit of Use]
GS1	06971712726370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121719

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

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: 2024-01-30
• Device Publish Date: 2024-01-22

Devices Manufactured by Hong Qiangxing (Shen Zhen) Electronics Limited

• 16971712720276 - Techcare: 2025-05-21 BLACK
• 16971712724724 - Techcare: 2025-05-21 BLACK COMBO SET
• 16971712725509 - Techcare: 2025-05-21 RED
• 26971712727593 - AUVON: 2025-04-08
• 26971712727616 - AUVON: 2025-04-08
• 26971712727654 - AUVON: 2025-04-08
• 06971712727650 - AUVON: 2025-04-08
• 16971712727817 - mastogo: 2025-03-28