FOH · Mattress, Water, Temperature Regulated
General Hospital · 21 CFR 880.5560 · Class 1
Overview
| Product Code | FOH |
|---|---|
| Device Name | Mattress, Water, Temperature Regulated |
| Regulation | 21 CFR 880.5560 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A temperature regulated water mattress is a device intended for medical purposes that consists of a mattress of suitable size, filled with water which can be heated or in some cases cooled. The device includes electrical heating and water circulating components, and an optional cooling component. The temperature control may be manual or automatic.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K954216 | OLYMPIC WARM-BASSINET | Olympic Medical Corp. | Dec 8, 1995 | SESE |
| K872876 | IMSI/EASY FLOAT MATTRESS | Intl. Management Services, Inc. | Oct 13, 1987 | SESE |
| K812683 | NEONATE FLEXFLOAT | Pharmaquest Corp. | Oct 13, 1981 | SESE |
| K812684 | ADULT FLEXFLOAT | Pharmaquest Corp. | Oct 8, 1981 | SESE |
| K812682 | FLEXFLOAT HEATER | Pharmaquest Corp. | Oct 8, 1981 | SESE |
| K812681 | ADULT FLEX FLOAT W/HEATER | Pharmaquest Corp. | Oct 8, 1981 | SESE |
Top Applicants
- Pharmaquest Corp. — 4 clearances
- Intl. Management Services, Inc. — 1 clearance
- Olympic Medical Corp. — 1 clearance
