Product code KIC
- Device name
- Cushion, Flotation
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3175
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960189 | GEL-T CUSHION | Span-America Medical Systems, Inc. | 1996-02-07 |
| K953352 | PROTEAM CUSHION | Iskra.Med | 1995-11-29 |
| K954117 | CUSTOMCARE SEATING SYSTEM | Span-America Medical Systems, Inc. | 1995-10-13 |
| K950085 | MULTICURE(R) S GEL PAD | Multigestion (Deutschland) GmbH | 1995-07-13 |
| K945667 | MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION | Micos Medical Systems | 1995-02-21 |
| K941858 | GEL CUSHION | Hollister, Inc. | 1994-05-05 |
| K911843 | ZERO-G(TM) GEL/FOAM MATTRESS TOPPER | Steridyne Corp. | 1991-05-30 |
| K872739 | SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION | D.A. Schulman, Inc. | 1987-07-30 |
| K864108 | PUSH CUSH | Medical Industries America, Inc. | 1986-11-14 |
| K864109 | C' AIRECUSH SEAT CUSHION | Medical Industries America, Inc. | 1986-11-14 |
| K861327 | ROHO HEEL PAD | Roho, Inc. | 1986-06-02 |
| K855072 | MAXIMUS CUSHION | Jay Medical, Ltd. | 1986-03-10 |
| K851814 | WHEELCHAIR CUSHIONS | Dignicare | 1985-07-09 |
| K851027 | SOF. CARE CUSHION & SOF-CARE CUSHION COVER | Gaymar Industries, Inc. | 1985-06-18 |
| K842380 | PRESSURE RELIEF SEAT CUSHION | American Pharmaseal Div. Ahsc | 1984-06-28 |
| K842120 | ZERO-G | Steridyne Corp. | 1984-06-08 |
| K834517 | JAY CUSHION | Jay Medical, Ltd. | 1984-01-17 |
| K831247 | SAFE-SEAT WHEELCHAIR CUSHION | D.A. Schulman, Inc. | 1983-05-16 |
| K830426 | INFLATABLE INVALID RING | Maddak, Inc. | 1983-04-28 |
| K830427 | ARM CUSHION | Maddak, Inc. | 1983-03-29 |
| K823903 | RUBBER INFLATABLE RING | Duro-Med Ind., Inc. | 1983-01-14 |
| K820236 | WATER FLOATATION PAD | Gottfried Medical, Inc. | 1982-02-04 |
| K813225 | GEL FLOTATION CUSHION | Jefferson Industries, Inc. | 1981-12-03 |
| K810649 | INVALID CUSHION | First Industries, Inc. | 1981-03-26 |
| K810440 | SILICONE ELBOW, BED AND CHAIR PADS | Fred Sammons, Inc. | 1981-03-12 |
| K803137 | CONPHAR INVALID RING | Conphar, Inc. | 1981-01-08 |
| K801217 | SKIL-CARE GEL WEDGE, FLOTATION PAD | Skil-Care Corp. | 1980-05-30 |
| K780941 | CONDUCTIVE CUSHION | Markham Service Co., Inc. | 1978-07-27 |
| K760613 | FLOTATION UNIT, CHAIR | Medpro, Inc. | 1976-10-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00613732113377 | ROHO QUADTRO SELECT HIGH PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113513 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113506 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113490 | ROHO QUADTRO SELECT MID PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113483 | ROHO QUADTRO SELECT MID PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113476 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113469 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113452 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113445 | ROHO QUADTRO SELECT MID PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113438 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113421 | ROHO QUADTRO SELECT MID PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113414 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113407 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113391 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113384 | ROHO QUADTRO SELECT HIGH PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113360 | ROHO QUADTRO SELECT HIGH PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113353 | ROHO QUADTRO SELECT HIGH PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113346 | ROHO QUADTRO SELECT HIGH PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113339 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113322 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113315 | ROHO QUADTRO SELECT HIGH PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113308 | ROHO QUADTRO SELECT HIGH PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113292 | ROHO QUADTRO SELECT HIGH PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113285 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113278 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113261 | ROHO QUADTRO SELECT HIGH PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113254 | ROHO QUADTRO SELECT LOW PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732113247 | ROHO QUADTRO SELECT HIGH PROFILE Cushion | Roho, Inc. | 2026-09-25 |
| 00613732079932 | ROHO Single Compartment Cushion | Roho, Inc. | 2022-11-25 |
| 00613732079949 | ROHO Single Compartment Cushion | Roho, Inc. | 2022-11-25 |