Tensmart

GUDID 06971712728961

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712728961
• NIH Device Record Key: f1a74708-5981-4e7a-8838-041dd72c61d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tensmart
• Version Model Number: TENS
• 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	06971712728954 [Primary]
GS1	06971712728961 [Unit of Use]

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: 2021-07-06
• Device Publish Date: 2021-06-28

Devices Manufactured by Hong Qiangxing (Shen Zhen) Electronics Limited

• 16971712727817 - mastogo: 2025-03-28
• 06971727219812 - Chirp: 2025-03-21
• 06971712727797 - Pulse Tec X-17: 2025-03-04
• 16971712722973 - Numiere: 2025-02-12
• 06971712729944 - takoo: 2025-01-30
• 16971712727466 - NURSAL: 2025-01-09 HPTS0237 silver
• 06971712727759 - Cloudix: 2025-01-08
• 06971727219706 - eMP10: 2025-01-08