Belifu

GUDID 00321906010758

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00321906010758
• NIH Device Record Key: 05b39e56-bbb1-4372-9de8-3f9ffa2737c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Belifu
• 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	00321906010758 [Primary]
GS1	00321907100007 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-07-02

On-Brand Devices [Belifu]

• 10119042900036: TENS
• 10019050701000: TENS
• 00321906010758: TENS
• 10819030700036: TENS
• 00321908130010: TENS
• 00321907130035: TENS
• 00321911080500: TENS
• 00321911210198: TENS
• 00322001030214: TENS
• 06971712723003: TENS
• 06971712723041: TENS
• 06971712723065: TENS
• 06971712723089: TENS
• 06971712723164: TENS
• 06971712723126: TENS
• 06971712723102: TENS
• 06971712723867: SM9126
• 06971712723836: SM9126
• 06971712723805: SM9126
• 06971712723683: SM9126
• 06971712723966: Electrode pads
• 06971712724024: SM9126
• 06971712724000: SM9126
• 06971712724093: SM9126
• 06971712724161: SM9126
• 06971712724147: SM9126
• 06971712724123: SM9126
• 06971712720996: SM9126
• 06971712721092: SM9126
• 06971712721108: SM9126
• 06971712721177: SM9126
• 06971712721252: SM9126
• 06971712721450: SM9126
• 06971712721399: SM9126
• 06971712721375: SM9126
• 06971712721436: SM9126
• 06971712721474: SM9126
• 06971712721740: SM9126
• 06971712721726: SM9126
• 06971712722198: SM9126
• 06971712722471: SM9126
• 06971712722457: SM9126
• 06971712722495: SM9126
• 06971712722570: SM9126
• 06971712722631: SM9126
• 06971712722617: SM9126
• 06971712722594: SM9126
• 06971712722518: SM9126
• 06971712722754: SM9126
• 06971712722730: SM9126