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- 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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Chronaximeter
- Page Type
- Product Code
- Regulation Medical Specialty
- Physical Medicine
- Review Panel
- Physical Medicine
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 890.1225
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 890.1225 Chronaximeter
§ 890.1225 Chronaximeter.
(a) Identification. A chronaximeter is a device intended for medical purposes to measure neuromuscular excitability by means of a strength-duration curve that provides a basis for diagnosis and prognosis of neurological dysfunction.
(b) Classification. Class II (performance standards).