KIC · Cushion, Flotation
Physical Medicine · 21 CFR 890.3175 · Class 1
Overview
| Product Code | KIC |
|---|---|
| Device Name | Cushion, Flotation |
| Regulation | 21 CFR 890.3175 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A flotation cushion is a device intended for medical purposes that is made of plastic, rubber, or other type of covering, that is filled with water, air, gel, mud, or any other substance allowing a flotation media, used on a seat to lessen the likelihood of skin ulcers.
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 § 890.9.
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960189 | GEL-T CUSHION | Span-America Medical Systems, Inc. | Feb 7, 1996 | SESE |
| K953352 | PROTEAM CUSHION | Iskra.Med | Nov 29, 1995 | SESE |
| K954117 | CUSTOMCARE SEATING SYSTEM | Span-America Medical Systems, Inc. | Oct 13, 1995 | SESE |
| K950085 | MULTICURE(R) S GEL PAD | Multigestion (Deutschland) GmbH | Jul 13, 1995 | SESE |
| K945667 | MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION | Micos Medical Systems | Feb 21, 1995 | SESE |
| K941858 | GEL CUSHION | Hollister, Inc. | May 5, 1994 | SESE |
| K911843 | ZERO-G(TM) GEL/FOAM MATTRESS TOPPER | Steridyne Corp. | May 30, 1991 | SESE |
| K872739 | SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION | D.A. Schulman, Inc. | Jul 30, 1987 | SESE |
| K864109 | C' AIRECUSH SEAT CUSHION | Medical Industries America, Inc. | Nov 14, 1986 | SESE |
| K864108 | PUSH CUSH | Medical Industries America, Inc. | Nov 14, 1986 | SESE |
| K861327 | ROHO HEEL PAD | Roho, Inc. | Jun 2, 1986 | SESE |
| K855072 | MAXIMUS CUSHION | Jay Medical, Ltd. | Mar 10, 1986 | SESE |
| K851814 | WHEELCHAIR CUSHIONS | Dignicare | Jul 9, 1985 | SESE |
| K851027 | SOF. CARE CUSHION & SOF-CARE CUSHION COVER | Gaymar Industries, Inc. | Jun 18, 1985 | SESE |
| K842380 | PRESSURE RELIEF SEAT CUSHION | American Pharmaseal Div. Ahsc | Jun 28, 1984 | SESE |
| K842120 | ZERO-G | Steridyne Corp. | Jun 8, 1984 | SESE |
| K834517 | JAY CUSHION | Jay Medical, Ltd. | Jan 17, 1984 | SESE |
| K831247 | SAFE-SEAT WHEELCHAIR CUSHION | D.A. Schulman, Inc. | May 16, 1983 | SESE |
| K830426 | INFLATABLE INVALID RING | Maddak, Inc. | Apr 28, 1983 | SESE |
| K830427 | ARM CUSHION | Maddak, Inc. | Mar 29, 1983 | SESE |
Top Applicants
- D.A. Schulman, Inc. — 2 clearances
- Jay Medical, Ltd. — 2 clearances
- Maddak, Inc. — 2 clearances
- Medical Industries America, Inc. — 2 clearances
- Span-America Medical Systems, Inc. — 2 clearances
