MOC · Cushion, Flotation, Therapeutic
Physical Medicine · 21 CFR 890.5170 · Class 2
Overview
| Product Code | MOC |
|---|---|
| Device Name | Cushion, Flotation, Therapeutic |
| Regulation | 21 CFR 890.5170 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K063175 | IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION) | Medical Technology Systems, Inc. | Mar 14, 2008 | SESE |
| K954162 | ERGOSEAT SYSTEM | Ergo-Air, Inc. | Oct 30, 1995 | SESE |
Top Applicants
- Ergo-Air, Inc. — 1 clearance
- Medical Technology Systems, Inc. — 1 clearance
