Company ยท US
Gaymar Industries, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2011. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DWJ | System, Thermal Regulating | 6 |
| ILO | Pack, Hot Or Cold, Water Circulating | 5 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 3 |
| IKZ | Bed, Patient Rotation, Powered | 2 |
| JOW | Sleeve, Limb, Compressible | 2 |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | 1 |
| FMT | Warmer, Infant Radiant | 1 |
| FNJ | Bed, Manual | 1 |
| FRW | Scale, Patient | 1 |
| IKY | Mattress, Flotation Therapy, Non-Powered | 1 |
| IMD | Pack, Hot Or Cold, Disposable | 1 |
| INX | Bed, Air Fluidized | 1 |
| IOQ | Bed, Flotation Therapy, Powered | 1 |
| KIC | Cushion, Flotation | 1 |
| KNN | Components, Wheelchair | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 20, 2011 | K100585 | MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 Gaymar Industries, Inc. | DWJ |
| May 8, 2008 | K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP Gaymar Industries, Inc. | ILO |
| Apr 30, 1997 | K962788 | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM Gaymar Industries, Inc. | IKZ |
| Jan 28, 1997 | K963067 | SOF. PRESS EPC 51 SYSTEM Gaymar Industries, Inc. | JOW |
| Aug 9, 1996 | K961854 | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 Gaymar Industries, Inc. | FNM |
| May 23, 1995 | K942881 | TC 3000 Gaymar Industries, Inc. | DWJ |
| Aug 6, 1993 | K930345 | TC2000 POWER UNIT AND ACCESSORIES Gaymar Industries, Inc. | DWJ |
| Mar 12, 1992 | K914921 | SCM-3 AND ACCESSORIES Gaymar Industries, Inc. | IKY |
| Jan 7, 1992 | K914805 | TC-1000, TC-1050 SYSTEM Gaymar Industries, Inc. | DWJ |
| Nov 13, 1991 | K914851 | CLA-1400 SYSTEM Gaymar Industries, Inc. | IOQ |
| Jul 30, 1991 | K912051 | MEDI-THERM (MTA-5900) & DETACHABLE HOSES Gaymar Industries, Inc. | DWJ |
| Jul 13, 1988 | K882092 | CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM Gaymar Industries, Inc. | FNM |
| May 23, 1988 | K882012 | LIFESTYLE SOF. CARE GEL CHAIR CUSHION Gaymar Industries, Inc. | KNN |
| Nov 8, 1985 | K852943 | NEO SHIELD Gaymar Industries, Inc. | FMT |
| Jun 18, 1985 | K851027 | SOF. CARE CUSHION & SOF-CARE CUSHION COVER Gaymar Industries, Inc. | KIC |
| Sep 26, 1983 | K832820 | MUL-T-BLANKET Gaymar Industries, Inc. | ILO |
| Sep 26, 1983 | K832819 | MUL-T-PAD Gaymar Industries, Inc. | ILO |
| Mar 6, 1981 | K810543 | NEO-WAVE SYSTEM Gaymar Industries, Inc. | INX |
| Apr 24, 1980 | K800812 | MEDI-THERM Gaymar Industries, Inc. | DWJ |
| Aug 10, 1978 | K780906 | AIR-FLO ALTERNATING PRESSURE PAD SYSTEM Gaymar Industries, Inc. | FNM |
| Jun 2, 1978 | K780471 | GASTRIC LAVAGE KIT Gaymar Industries, Inc. | FAT |
| Jul 21, 1977 | K771083 | SEQUENTIAL PRESSURE CUFF Gaymar Industries, Inc. | JOW |
| Nov 12, 1976 | K760545 | WEIGHING STATION, MOBILE PATIENT Gaymar Industries, Inc. | FRW |
| Oct 15, 1976 | K760804 | T-PUMP, TEMPERATURE - THERAPY PUMP Gaymar Industries, Inc. | ILO |
| Oct 6, 1976 | K760706 | MUL-T-PAD Gaymar Industries, Inc. | IMD |
| Sep 3, 1976 | K760527 | T-PAD Gaymar Industries, Inc. | ILO |
| Aug 11, 1976 | K760315 | PAD, POLYETHER FOAM, OPEN CELL Gaymar Industries, Inc. | FNJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2004 | Gaymar Industries Inc 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 fi Terminated |
IKZ | None listed |