PowerDot PD-01

GUDID 04719872330325

PowerDot PD-01 Muscle Stimulator, Red (with PowerDot Mobile Application)

ZMI ELECTRONICS LTD.

Physical therapy ultrasound/neuromuscular stimulation system

• Primary Device ID: 04719872330325
• NIH Device Record Key: 60d71afa-e872-414e-8275-7af53165ed9d
• Commercial Distribution Discontinuation: 2099-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerDot
• Version Model Number: PD-01R
• Catalog Number: PD-01
• Company DUNS: 657406062
• Company Name: ZMI ELECTRONICS LTD.
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872330325 [Primary]
GS1	04719872330363 [Package]; Package: Color Box [1 Units]; Discontinued: 2099-12-31; In Commercial Distribution
GS1	14719872330360 [Package]; Package: Color Box [2 Units]; Discontinued: 2099-12-31; In Commercial Distribution

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [PowerDot]

• 04719872330394: PowerDot PD-01M Muscle Stimulator, Red (with PowerDot Mobile Application)
• 04719872330387: PowerDot PD-01M Muscle Stimulator, Black (with PowerDot Mobile Application)
• 04719872330332: PowerDot PD-01 Muscle Stimulator, White (with PowerDot Mobile Application)
• 04719872330325: PowerDot PD-01 Muscle Stimulator, Red (with PowerDot Mobile Application)
• 04719872330318: PowerDot PD-01 Muscle Stimulator, Black (with PowerDot Mobile Application)
• 04719872330639: Self-adhesive electrode, butterfly type
• 04719872330622: Self-adhesive electrode package (with magnetic snap) , Blue, Each package contains electrode d
• 04719872330615: PowerDot PD-01MT Muscle Stimulator, Blue
• 04719872330929: Self-adhesive electrode package (with magnetic snap) , American Flag , Each package contains e