Omron Focus TENS Therapy for Knee - Large

Basic Information

• Brand Name: Omron Focus TENS Therapy for Knee - Large
• Primary DI: 00073796637125
• Version / Model: PM710-L
• Catalog Number: PM710-L
• Company Name: Omron Healthcare, Inc.
• Labeler DUNS: 054318779
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-15
• Public Version: 1
• Public Version Date: 2020-01-23
• Public Version Status: New
• Public Device Record Key: 686ae7a2-e6cf-4b94-a4a6-9e8ba3dceb00

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	882.5890	2
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	882.5890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35372	Analgesic transcutaneous electrical nerve stimulation system	An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00073796637125	GS1
Package	10073796637122	GS1	Case	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K183215	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit