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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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Hammer, Reflex, Powered
- Page Type
- Product Code
- Regulation Medical Specialty
- Physical Medicine
- Review Panel
- Physical Medicine
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 2
- Regulation Number
- 890.1450
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 890.1450 Powered reflex hammer
§ 890.1450 Powered reflex hammer.
(a) Identification. A powered reflex hammer is a motorized device intended for medical purposes to elicit and determine controlled deep tendon reflexes.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]