Bottle, Hot/Cold Water
The Hot/Cold Water Bottle is a medical-grade container filled with hot or cold water applied to areas of the body to provide thermal therapy for pain relief, muscle relaxation, or fever reduction. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FPF, regulated under 21 CFR 880.6085 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- FPF
- Device Class
- FDA class 1
- Regulation Number
- 880.6085
- 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 |
|---|---|---|---|---|
| K791176 | 3M COLD/HOT WATER BAG AND WRAP | Jul 30, 1979 | Substantially Equivalent | 3M Company |
FEI Numbers
This FDA classification entry is associated with 71 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 71 registration numbers. Click on an entry to view related FDA registrations.