Cover, Cast
Cast Cover is a protective accessory designed to be placed over an orthopedic cast, typically to shield the cast and underlying limb from water during bathing or other activities, preventing cast damage and maintaining skin hygiene beneath the cast. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KIA, regulated under 21 CFR 880.6185, within the General Hospital medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- KIA
- Device Class
- FDA class 1
- Regulation Number
- 880.6185
- 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 |
|---|---|---|---|---|
| K791646 | PLASTIC SHOWER GUARD | Oct 01, 1979 | Substantially Equivalent | B & F Medical Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 74 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 74 registration numbers. Click on an entry to view related FDA registrations.