Last synced on 27 January 2023 at 11:04 pm

Neuromuscular Tongue Stimulator To Treat Motor Deficits

Page Type
Product Code
Definition
A neuromuscular tongue stimulator to treat motor deficits is a prescription device that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the nerves in the tongue to provide treatment of motor deficits.
Physical State
Software
Technical Method
Patient uses software on computer.
Target Area
Brain
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5889
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 QCF is linked to regulation 21CFR882.5889, which does not seem to exist yet. It may be pending at the moment.

Neuromuscular Tongue Stimulator To Treat Motor Deficits

Page Type
Product Code
Definition
A neuromuscular tongue stimulator to treat motor deficits is a prescription device that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the nerves in the tongue to provide treatment of motor deficits.
Physical State
Software
Technical Method
Patient uses software on computer.
Target Area
Brain
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5889
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 QCF is linked to regulation 21CFR882.5889, which does not seem to exist yet. It may be pending at the moment.