SOF. CARE CUSHION & SOF-CARE CUSHION COVER
FDA 510(k) clearance K851027 · decided 1985-06-18
Clearance details
- K-number
- K851027
- Device name
- SOF. CARE CUSHION & SOF-CARE CUSHION COVER
- Applicant
- Gaymar Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-12
- Decision date
- 1985-06-18
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- KIC
- Device class
- 1
- Regulation number
- 890.3175
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Orchard Park, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gaymar Industries
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GEL-T CUSHION (K960189) | Span-America Medical Systems, Inc. | 1996-02-07 |
| PROTEAM CUSHION (K953352) | Iskra.Med | 1995-11-29 |
| CUSTOMCARE SEATING SYSTEM (K954117) | Span-America Medical Systems, Inc. | 1995-10-13 |
| MULTICURE(R) S GEL PAD (K950085) | Multigestion (Deutschland) GmbH | 1995-07-13 |
| MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION (K945667) | Micos Medical Systems | 1995-02-21 |
| GEL CUSHION (K941858) | Hollister, Inc. | 1994-05-05 |
| ZERO-G(TM) GEL/FOAM MATTRESS TOPPER (K911843) | Steridyne Corp. | 1991-05-30 |
| SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION (K872739) | D.A. Schulman, Inc. | 1987-07-30 |
| C' AIRECUSH SEAT CUSHION (K864109) | Medical Industries America, Inc. | 1986-11-14 |
| PUSH CUSH (K864108) | Medical Industries America, Inc. | 1986-11-14 |
| ROHO HEEL PAD (K861327) | Roho, Inc. | 1986-06-02 |
| MAXIMUS CUSHION (K855072) | Jay Medical, Ltd. | 1986-03-10 |
Recalls involving this device
No recalls on record reference this clearance.