NEOCARBON

GUDID 06971712726967

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712726967
• NIH Device Record Key: 749b31b8-dbe7-4a84-9f53-9c0d7b5e5f8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEOCARBON
• 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	06971712726967 [Unit of Use]
GS1	06971712726974 [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: 2024-07-08
• Device Publish Date: 2024-06-28

On-Brand Devices [NEOCARBON]

• 06971712724178: SM9910
• 06971712724215: SM9910
• 06971712724239: SM9910
• 06971712721146: SM9910
• 06971712721764: SM9910
• 06971712722211: SM9910
• 06971712722334: SM9910
• 06971712722716: SM9910
• 06971712724833: SM9910
• 06971712724819: SM9910
• 06971712724796: SM9910
• 06971712724970: SM9910
• 06971712724956: SM9910
• 06971712725137: SM9128
• 06971712725014: SM9910
• 06971712724604: SM9910
• 06971712724529: SM9910
• 06971712722914: SM9910
• 06971712725236: SM9126
• 06971712725373: SM9126
• 06971712725649: SM9126
• 06971712725625: SM9126
• 06971712725847: SM9126
• 06971712725823: SM9126
• 06971712725861: SM9126
• 06971712725885: SM9126
• 06971712726028: SM9126
• 06971712726042: SM9126
• 06971712726202: SM9126
• 06971712726189: SM9126
• 06971712726981: TENS
• 06971712726967: TENS
• 06971712727940: TENS & PMS
• 06971712727919: TENS & PMS
• 06971712727872: TENS & PMS
• 06971712727858: TENS & PMS
• 06971712727889: TENS & PMS