Mattress, Water, Temperature Regulated
The Temperature-Regulated Water Mattress is a device that circulates temperature-controlled water through a mattress surface to warm or cool a patient, used in therapeutic hypothermia or hyperthermia treatment and post-operative temperature management. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FOH, regulated under 21 CFR 880.5560 in the General Hospital specialty.
Research product code FOH in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- FOH
- Device Class
- FDA class 1
- Regulation Number
- 880.5560
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K954216 | OLYMPIC WARM-BASSINET | Dec 08, 1995 | Substantially Equivalent | Olympic Medical Corp. |
| K872876 | IMSI/EASY FLOAT MATTRESS | Oct 13, 1987 | Substantially Equivalent | Intl. Management Services, Inc. |
| K812683 | NEONATE FLEXFLOAT | Oct 13, 1981 | Substantially Equivalent | Pharmaquest Corp. |
| K812684 | ADULT FLEXFLOAT | Oct 08, 1981 | Substantially Equivalent | Pharmaquest Corp. |
| K812682 | FLEXFLOAT HEATER | Oct 08, 1981 | Substantially Equivalent | Pharmaquest Corp. |
| K812681 | ADULT FLEX FLOAT W/HEATER | Oct 08, 1981 | Substantially Equivalent | Pharmaquest Corp. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.