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- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- IKDCable, Electrode2Product Code
- IKETransducer, Miniature Pressure1Product Code
- IKKSystem, Isokinetic Testing And Evaluation2Product Code
- IKOHammer, Reflex, Powered2Product Code
- IKPChronaximeter2Product Code
- ISBStimulator, Muscle, Diagnostic2Product Code
- JFCSystem, Pressure Measurement, Intermittent1Product Code
- KHXPlatform, Force-Measuring1Product Code
- OALExercise Equipment, Powered, Emg-Triggered2Product Code
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
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Exercise Equipment, Powered, Emg-Triggered
- Page Type
- Product Code
- Definition
- To provide rehabilitation (e.G., increasing range of motion, muscle re-education) through emg-triggered powered exercise. Increasing range of motion and muscle re-education.
- Physical State
- EMG sensor, plus other apparatus such as a DC motor, limb orthosis, and connecting cables through which tension is applied.
- Technical Method
- EMG in affected area is sensed, processed, and used as an input to control a DC motor or other actuator that applies a force/torque to move an affected joint through range of motion.
- Target Area
- Typically, such a device will be used on the upper extremity or possibily the lower extremity.
- Regulation Medical Specialty
- Physical Medicine
- Review Panel
- Physical Medicine
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 890.1375
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
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CFR § 890.1375 Diagnostic electromyograph
§ 890.1375 Diagnostic electromyograph.
(a) Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.
(b) Classification. Class II (performance standards).