Hi-Dow

GUDID 00851640007016

AcuXP iSmart Black

Hi-Dow International Incorporated

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00851640007016
• NIH Device Record Key: 8acfa704-d2b5-4865-a61a-680e4cd505a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hi-Dow
• Version Model Number: JQ-5C-E
• Company DUNS: 124034476
• Company Name: Hi-Dow International Incorporated
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851640007016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102598

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-28
• Device Publish Date: 2016-09-01

On-Brand Devices [Hi-Dow]

• 00851640007474: Wired Electronic Muscle Stimulator , XPDS-4-24
• 00851640007399: Wireless-49 TENS/EMS System
• 00851640007016: AcuXP iSmart Black