Prescription Starter Kit for Government Markets (includes 1 Device, 2 Packs of Quell Electrodes with UDI 00851221006018, 1 Charger, 1 Charger Cable, 1 Sport Band)

Prescription Starter Kit for Government Markets (includes 1 Device, 2 Packs of Quell Electrodes with UDI 00851221006018, 1 Charger, 1 Charger Cable, 1 Sport Band)
QUELL FIBROMYALGIA - QE-FMG

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 Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QSQ

Device Name: Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms

Device Class: 2

Physical State: Electrical stimulation unit with leads and cutaneous electrodes.

Definition: Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Applies an electrical current through electrodes on patient's skin.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Sensory nerves

Regulation Number: 882.5888

Third Party Flag: N

Medical Specialty: NE

Device Id: 00851221006643

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