Last synced on 2 December 2022 at 11:04 pm

Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms

Page Type
Product Code
Definition
Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.
Physical State
Electrical stimulation unit with leads and cutaneous electrodes.
Technical Method
Applies an electrical current through electrodes on patient's skin.
Target Area
Sensory nerves
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5888
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 QSQ is linked to regulation 21CFR882.5888, which does not seem to exist yet. It may be pending at the moment.

Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms

Page Type
Product Code
Definition
Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.
Physical State
Electrical stimulation unit with leads and cutaneous electrodes.
Technical Method
Applies an electrical current through electrodes on patient's skin.
Target Area
Sensory nerves
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5888
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 QSQ is linked to regulation 21CFR882.5888, which does not seem to exist yet. It may be pending at the moment.