Title 21

SECTION 880.6280

880.6280 Medical insole.

§ 880.6280 Medical insole.

(a) Identification. A medical insole is a device intended for medical purposes that is placed inside a shoe to relieve the symptoms of athlete's foot infection by absorbing moisture.

(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 the limitations in § 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38806, July 25, 2001]

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