MASTOGO

GUDID 06971712727285

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06971712727285
• NIH Device Record Key: df99fbf0-94f2-444b-bf60-fff3ccc08c4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MASTOGO
• Version Model Number: TENS
• Company DUNS: 421286946
• Company Name: Hong Qiangxing (Shen Zhen) Electronics Limited
• Device Count: 48
• 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	06971712727285 [Unit of Use]
GS1	06971712727292 [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: 2024-10-08
• Device Publish Date: 2024-09-30

On-Brand Devices [MASTOGO]

• 06971712721535: TENS
• 06971712720514: TENS
• 06971712720804: TENS
• 06971712720828: TENS
• 06971712720842: TENS
• 06971712720880: TENS
• 06971712721238: TENS
• 06971712722297: TENS
• 06971712722358: TENS
• 06971712725038: TENS
• 06971712725052: TENS
• 06971712722419: TENS
• 06971712725564: TENS
• 06971712725922: SM9187
• 06971712725816: TENS
• 06971712726509: TENS
• 06971712726745: TENS
• 06971712726806: TENS
• 06971712726783: TENS
• 06971712726769: TENS
• 06971712726844: TENS
• 06971712726943: TENS
• 06971712727124: TENS
• 06971712727285: TENS
• 06971712727827: SM9187
• 06971712727803: SM9187
• 06971712727780: SM9187
• 06971712727766: SM9187
• 06971712729586: SM9187
• 06971712729555: SM9187
• 06971712727995: SM9187
• 06971712727971: SM9187
• 06971712727957: SM9187