Last synced on 14 June 2024 at 11:05 pm

Stimulator, Nerve, For Restless Legs Syndrome

Page Type
Product Code
Definition
An external lower extremity nerve stimulator for Restless Legs Syndrome is a prescription device that uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity (e.g.,peroneal nerves) and evoke tonic, sustained muscle activation in the legs to reduce the symptoms of Restless Legs Syndrome.
Physical State
electrical stimulation unit with cutaneous electrodes
Technical Method
applies electrical currents through electrodes on patient's skin
Target Area
peroneal nerves
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5887
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QWD is linked to regulation 21CFR882.5887, which does not seem to exist yet. It may be pending at the moment.

Stimulator, Nerve, For Restless Legs Syndrome

Page Type
Product Code
Definition
An external lower extremity nerve stimulator for Restless Legs Syndrome is a prescription device that uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity (e.g.,peroneal nerves) and evoke tonic, sustained muscle activation in the legs to reduce the symptoms of Restless Legs Syndrome.
Physical State
electrical stimulation unit with cutaneous electrodes
Technical Method
applies electrical currents through electrodes on patient's skin
Target Area
peroneal nerves
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5887
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QWD is linked to regulation 21CFR882.5887, which does not seem to exist yet. It may be pending at the moment.