Gaymar Industries, Inc.
Buffalo, NY, US
Gaymar Industries, Inc. appears in FDA device records in Buffalo, NY. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 27 510(k) clearances for Gaymar Industries, Inc. between 1976 and 2011. The busiest year on record is 1976, with 5. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 5 |
| 1977 | 1 |
| 1978 | 2 |
| 1980 | 1 |
| 1981 | 1 |
| 1983 | 2 |
| 1985 | 2 |
| 1988 | 2 |
| 1991 | 2 |
| 1992 | 2 |
| 1993 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 2 |
| 2008 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K100585 | MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 | DWJ | Substantially Equivalent | |
| K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | ILO | Substantially Equivalent | |
| K962788 | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM | IKZ | Substantially Equivalent | |
| K963067 | SOF. PRESS EPC 51 SYSTEM | JOW | Substantially Equivalent | |
| K961854 | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 | FNM | Substantially Equivalent | |
| K942881 | TC 3000 | DWJ | Substantially Equivalent | |
| K930345 | TC2000 POWER UNIT AND ACCESSORIES | DWJ | Substantially Equivalent | |
| K914921 | SCM-3 AND ACCESSORIES | IKY | Substantially Equivalent | |
| K914805 | TC-1000, TC-1050 SYSTEM | DWJ | Substantially Equivalent | |
| K914851 | CLA-1400 SYSTEM | IOQ | Substantially Equivalent | |
| K912051 | MEDI-THERM (MTA-5900) & DETACHABLE HOSES | DWJ | Substantially Equivalent | |
| K882092 | CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM | FNM | Substantially Equivalent | |
| K882012 | LIFESTYLE SOF. CARE GEL CHAIR CUSHION | KNN | Substantially Equivalent | |
| K852943 | NEO SHIELD | FMT | Substantially Equivalent | |
| K851027 | SOF. CARE CUSHION & SOF-CARE CUSHION COVER | KIC | Substantially Equivalent | |
| K832820 | MUL-T-BLANKET | ILO | Substantially Equivalent | |
| K832819 | MUL-T-PAD | ILO | Substantially Equivalent | |
| K810543 | NEO-WAVE SYSTEM | INX | Substantially Equivalent | |
| K800812 | MEDI-THERM | DWJ | Substantially Equivalent | |
| K780906 | AIR-FLO ALTERNATING PRESSURE PAD SYSTEM | FNM | Substantially Equivalent | |
| K780471 | GASTRIC LAVAGE KIT | FAT | Substantially Equivalent | |
| K771083 | SEQUENTIAL PRESSURE CUFF | JOW | Substantially Equivalent | |
| K760545 | WEIGHING STATION, MOBILE PATIENT | FRW | Substantially Equivalent | |
| K760804 | T-PUMP, TEMPERATURE - THERAPY PUMP | ILO | Substantially Equivalent | |
| K760706 | MUL-T-PAD | IMD | Substantially Equivalent | |
| K760527 | T-PAD | ILO | Substantially Equivalent | |
| K760315 | PAD, POLYETHER FOAM, OPEN CELL | FNJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- INXBed, Air Fluidized
- IOQBed, Flotation Therapy, Powered
- FNJBed, Manual
- IKZBed, Patient Rotation, Powered
- FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology
- KNNComponents, Wheelchair
- KICCushion, Flotation
- FNMMattress, Air Flotation, Alternating Pressure
- IKYMattress, Flotation Therapy, Non-Powered
- IMDPack, Hot Or Cold, Disposable
- ILOPack, Hot Or Cold, Water Circulating
- FRWScale, Patient
- JOWSleeve, Limb, Compressible
- DWJSystem, Thermal Regulating
- FMTWarmer, Infant Radiant
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0260-05 | XPRT Therapy Mattress Systems: Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without coating (standard cover). Responsible firm on the label: Manufactured for STRYKER MEDICAL, 6300 South Sprinkle Road, Kalamazoo, MI USA 49001-9799, 1-800-327-0770. The unit consists of a sleep surface, an integrated valve box located in the head of the mattress, a pump box located under the foot of the mattress and a color touch screen controller that can be mounted to either side of the pump box at the foot end of the mattress. | Design control/validation deficiencies. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain