TrueStim

GUDID 00851640007429

TrueStim Premium Stimulation System

Hi-Dow International Incorporated

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00851640007429
• NIH Device Record Key: cfb8e67c-7b0c-44c8-9545-4afe42edb34d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrueStim
• Version Model Number: HD-5N-Y
• 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	00851640007429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163393

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: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-04-04

On-Brand Devices [TrueStim]

• 00851640007429: TrueStim Premium Stimulation System
• 00851640007207: TrueStim Premium Stimulation System 6-12
• 00851640007139: Wired Classic Stimulation System BLACK
• 00851640007122: Wired Classic Stimulation System WHITE
• 00851640007900: Pulsed Electromagnetic Field Wrap,,LUMBAR WRAP Black
• 00851640007931: Pulsed Electromagnetic Field Wrap Black Neck Wrap
• 00851640007917: Pulsed Electromagnetic Field Wrap, Black, Knee Wrap
• 00851640007924: Pulsed Electromagnetic Field Wrap,,SHOULDER WRAP Black
• 00081009308007: Pulsed Electromagnetic Field Wrap, Black, lower limb wrap