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(a)Identification. A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation. (b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 882.9. [44 FR 51730-51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000]
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