Insoles, Medical
Medical Insoles are orthopedic devices placed inside footwear to provide cushioning, arch support, pressure redistribution, or correction of foot alignment, used in the management of plantar fasciitis, diabetic foot conditions, and other podiatric complaints. They are classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KYS, regulated under 21 CFR 880.6280, in the General Hospital medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KYS
- Device Class
- FDA class 1
- Regulation Number
- 880.6280
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K780719 | FUNGUS FIGHTER INSOLES | Oct 10, 1978 | Substantially Equivalent | Combe, Inc. |
FEI Numbers
This FDA classification entry is associated with 120 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 120 registration numbers. Click on an entry to view related FDA registrations.