KYS · Insoles, Medical
General Hospital · 21 CFR 880.6280 · Class 1
Overview
| Product Code | KYS |
|---|---|
| Device Name | Insoles, Medical |
| Regulation | 21 CFR 880.6280 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
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.
Classification Rationale
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K780719 | FUNGUS FIGHTER INSOLES | Combe, Inc. | Oct 10, 1978 | SESE |
Top Applicants
- Combe, Inc. — 1 clearance
