Eliking

GUDID 00416100100005

Hong Qiangxing (Shen Zhen) Electronics Limited

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00416100100005
• NIH Device Record Key: 19a1aeeb-e47d-4000-bab1-931d49153ee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eliking
• Version Model Number: TENS
• Company DUNS: 421286946
• Company Name: Hong Qiangxing (Shen Zhen) Electronics Limited
• Device Count: 2002
• DM Exempt: false
• 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: true
• 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	00416100100004 [Unit of Use]
GS1	00416100100005 [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: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-10-15

On-Brand Devices [Eliking]

• 00416100100005: TENS
• 00071706010024: TENS
• 00041611010008: TENS
• 06971712721351: SM9186
• 06971712721337: SM9186
• 06971712726929: SM9128D
• 06971712726905: SM9128D
• 06971712726882: SM9909
• 06971712726868: SM9200