Cushion, Flotation
FDA product code KIC · Class I (low risk) · 21 CFR 890.3175 · Physical Medicine
29510(k) clearances
0PMA approvals
1recalls
Manufacturers
- D.A. Schulman, Inc. 2
- Span-America Medical Systems, Inc. 2
- Medical Industries America, Inc. 2
- Steridyne Corp. 2
- Jay Medical, Ltd. 2
- Maddak, Inc. 2
- Jefferson Industries, Inc. 1
- Gottfried Medical, Inc. 1
- Duro-Med Ind., Inc. 1
- First Industries, Inc. 1
- Medpro, Inc. 1
- Fred Sammons, Inc. 1
- Conphar, Inc. 1
- American Pharmaseal Div. Ahsc 1
- Gaymar Industries, Inc. 1
- Dignicare 1
- Roho, Inc. 1
- Skil-Care Corp. 1
- Hollister, Inc. 1
- Iskra.Med 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960189 | Gel-T CushionKIC · Traditional | Span-America Medical Systems, Inc. | 02/07/1996SE |
| K953352 | Proteam CushionKIC · Traditional | Iskra.Med | 11/29/1995SE |
| K954117 | Customcare Seating SystemKIC · Traditional | Span-America Medical Systems, Inc. | 10/13/1995SE |
| K950085 | Multicure(R) S Gel PadKIC · Traditional | Multigestion (Deutschland) GmbH | 07/13/1995SE |
| K945667 | Micos Micropulse(Tm) Alternating Pressure Wheelchair CushionKIC · Traditional | Micos Medical Systems | 02/21/1995SE |
| K941858 | Gel CushionKIC · Traditional | Hollister, Inc. | 05/05/1994SE |
| K911843 | Zero-G(Tm) Gel/Foam Mattress TopperKIC · Traditional | Steridyne Corp. | 05/30/1991SE |
| K872739 | Safe-Seat, Low-Profile Wheelchair CushionKIC · Traditional | D.A. Schulman, Inc. | 07/30/1987SE |
| K864109 | C' Airecush Seat CushionKIC · Traditional | Medical Industries America, Inc. | 11/14/1986SE |
| K864108 | Push CushKIC · Traditional | Medical Industries America, Inc. | 11/14/1986SE |
| K861327 | Roho Heel PadKIC · Traditional | Roho, Inc. | 06/02/1986SE |
| K855072 | Maximus CushionKIC · Traditional | Jay Medical, Ltd. | 03/10/1986SE |
| K851814 | Wheelchair CushionsKIC · Traditional | Dignicare | 07/09/1985SE |
| K851027 | Sof. Care Cushion & Sof-Care Cushion CoverKIC · Traditional | Gaymar Industries, Inc. | 06/18/1985SE |
| K842380 | Pressure Relief Seat CushionKIC · Traditional | American Pharmaseal Div. Ahsc | 06/28/1984SE |
| K842120 | Zero-GKIC · Traditional | Steridyne Corp. | 06/08/1984SE |
| K834517 | Jay CushionKIC · Traditional | Jay Medical, Ltd. | 01/17/1984SE |
| K831247 | Safe-Seat Wheelchair CushionKIC · Traditional | D.A. Schulman, Inc. | 05/16/1983SE |
| K830426 | Inflatable Invalid RingKIC · Traditional | Maddak, Inc. | 04/28/1983SE |
| K830427 | Arm CushionKIC · Traditional | Maddak, Inc. | 03/29/1983SE |
| K823903 | Rubber Inflatable RingKIC · Traditional | Duro-Med Ind., Inc. | 01/14/1983SE |
| K820236 | Water Floatation PadKIC · Traditional | Gottfried Medical, Inc. | 02/04/1982SE |
| K813225 | Gel Flotation CushionKIC · Traditional | Jefferson Industries, Inc. | 12/03/1981SE |
| K810649 | Invalid CushionKIC · Traditional | First Industries, Inc. | 03/26/1981SE |
| K810440 | Silicone Elbow, Bed and Chair PadsKIC · Traditional | Fred Sammons, Inc. | 03/12/1981SE |
| K803137 | Conphar Invalid RingKIC · Traditional | Conphar, Inc. | 01/08/1981SE |
| K801217 | Skil-Care Gel Wedge, Flotation PadKIC · Traditional | Skil-Care Corp. | 05/30/1980SE |
| K780941 | Conductive CushionKIC · Traditional | Markham Service Co., Inc. | 07/27/1978SE |
| K760613 | Flotation Unit, ChairKIC · Traditional | Medpro, Inc. | 10/14/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1921-2017 Class II | ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID…When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may… | Roho Inc. | 03/20/2017Terminated |