CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES > SUBPART G—General Hospital and Personal Use Miscellaneous Devices (§880.6025 to §880.6992) > 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.

Code of Federal Regulations

[45 FR 69682-69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38806, July 25, 2001]