Omron Focus TENS Therapy for Knee - Large PM710-L

GUDID 00073796637125

Omron TENS unit is wearable and wireless, battery operated and includes the device, case, band and pad.

Omron Healthcare, Inc.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00073796637125
• NIH Device Record Key: 686ae7a2-e6cf-4b94-a4a6-9e8ba3dceb00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Focus TENS Therapy for Knee - Large
• Version Model Number: PM710-L
• Catalog Number: PM710-L
• Company DUNS: 054318779
• Company Name: Omron Healthcare, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-634-4350
• Email: ohiquality@omron.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796637125 [Primary]
GS1	10073796637122 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183215

FDA Product Code

• NYN: Stimulator, Electrical, Transcutaneous, For Arthritis

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-23
• Device Publish Date: 2020-01-15

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