DOMAS

GUDID 19042072888016

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 19042072888016
• NIH Device Record Key: 66162714-0788-4b42-b8e7-84cf41f22765
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOMAS
• 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	19042072541010 [Unit of Use]
GS1	19042072888016 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-05-07

On-Brand Devices [DOMAS]

• 45612896535899: TENS
• 19011108360505: TENS
• 19042072888016: TENS
• 06971712721054: TENS
• 06971712722228: TENS
• 06971712720491: TENS
• 06971712728084: TENS
• 06971712721511: TENS
• 06971712721030: TENS
• 06971712721016: TENS
• 06971712720378: TENS
• 06971712720347: TENS
• 06971712728862: TENS
• 06971712728848: TENS
• 06971712720576: TENS
• 06971712720866: TENS
• 06971712721412: SM9910
• 06971712721122: SM9910
• 06971712721078: SM9128M
• 06971712721566: SM9910
• 06971712721580: SM9910
• 06971712721689: SM9910
• 06971712722051: TENS
• 06971712722112: TENS
• 06971712722310: SM9065
• 06971712722396: TENS
• 06971712722372: TENS
• 06971712722693: TENS
• 06971712722839: TENS
• 06971712722990: TENS
• 06971712724567: TENS
• 06971712725090: TENS
• 06971712725076: TENS
• 06971712725311: SM9126
• 06971712725335: SM9126
• 06971712725359: SM9126
• 06971712725908: SM9065