- Physicians Office Resource

Amazon Quell 2.0 Device Box (includes device, 1 electrode with UDI 00851221006018 and/or UDI 00851221006049, 1 charger, 1 charger cable, 1 sport band)
QUELL 2.0 - QE-NAZ

Device Description

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.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

70.00
-25.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NUH

Device Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Device Class: 2

Physical State: N/A

Definition: TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 882.5890

Third Party Flag: Y

Medical Specialty: NE

Device Identifiers

Device Id: 00851221006483

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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