Bag, Ice
The Ice Bag is a general-purpose device consisting of a flexible container filled or fillable with ice, used to apply cold therapy to reduce swelling, pain, or inflammation following injury or surgery. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is KYR, regulated under 21 CFR 880.6050, in the General Hospital medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- KYR
- Device Class
- FDA class 1
- Regulation Number
- 880.6050
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K833872 | SAV-A-LIMB | Feb 04, 1984 | Substantially Equivalent | Sil-Med Corp. |
| K810653 | VINYL ICE BAG | Mar 27, 1981 | Substantially Equivalent | First Industries, Inc. |
| K780608 | ICE BAG, VINYL | Jun 06, 1978 | Substantially Equivalent | Abco Dealers, Inc. |
| K760951 | DEVON COOL FACE | Dec 30, 1976 | Substantially Equivalent | Devon Industries, Inc. |
FEI Numbers
This FDA classification entry is associated with 166 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 166 registration numbers. Click on an entry to view related FDA registrations.