Stimulator, Muscle, Powered, Dental

Device Code: 1395

Product Code(s): NUW

Definition: Relief Of Muscle Spasms Associated With Tmj. Muscle Reeducation, Increasing Blood Flow.

Device Classification Information

• Device Type ID: 1395
• Device Name: Stimulator, Muscle, Powered, Dental
• Regulation Description: Powered Muscle Stimulator.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Dental
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Dental Devices Branch (DEDB)
• Submission Type: 510(k)
• CFR Regulation Number: 890.5850 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NUW
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 17-16 IEC 60601-2-10 Edition 2.1 2016-04
  Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators

Total Product Life Cycle

• Device Type ID: 1395
• Device: Stimulator, Muscle, Powered, Dental
• Product Code: NUW
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Powered Muscle Stimulator.
• CFR Regulation Number: 890.5850 [🔎]

TPLC Last Update: 2019-04-02 19:53:23