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.
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.