Skil-Care Corp.
New Rochelle, NY, US
SKIL-CARE CORP. appears in FDA device records in New Rochelle, NY. FDA records list 20 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 20 510(k) clearances for Skil-Care Corp. between 1979 and 2001. The busiest year on record is 1996, with 12. The most recent is 2001, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 3 |
| 1980 | 3 |
| 1996 | 12 |
| 2001 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K010818 | INFANT LIMB HOLDER, MODELS 306080 & 306081 | FMQ | Substantially Equivalent | |
| K010644 | CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 | FMQ | Substantially Equivalent | |
| K963458 | PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS | FMQ | Substantially Equivalent | |
| K963459 | SUPPORT VEST | KID | Substantially Equivalent | |
| K963461 | SAFETY PONCHO/SHOULDER STRAP PONCHO | KID | Substantially Equivalent | |
| K963460 | ROLL BELT | FMQ | Substantially Equivalent | |
| K963457 | SLEEPER JACKET/HOUDINI SAFETY SLEEPER | FMQ | Substantially Equivalent | |
| K963456 | LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER | FMQ | Substantially Equivalent | |
| K963455 | SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL | KID | Substantially Equivalent | |
| K963454 | CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT | FMQ | Substantially Equivalent | |
| K963450 | SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST | FMQ | Substantially Equivalent | |
| K963449 | PELVIC HOLDER | FMQ | Substantially Equivalent | |
| K963448 | ECONO BELT | FMQ | Substantially Equivalent | |
| K963447 | DOUBLE SUPPORT PONCHO/SLIDER PONCHO | FMQ | Substantially Equivalent | |
| K801489 | EZ ON SAFETY PONCHO | KNO | Substantially Equivalent | |
| K801217 | SKIL-CARE GEL WEDGE, FLOTATION PAD | KIC | Substantially Equivalent | |
| K800208 | SKIL-CARE LEG PADS | KNO | Substantially Equivalent | |
| K792318 | SKIL-CARE TURN AND HOLD PAD | FMR | Substantially Equivalent | |
| K792012 | SKIL-CARE SUPER-SOFT LIMB RESTRAINTS | FMQ | Substantially Equivalent | |
| K791993 | SKIL-CARE BED RAIL PADS | FNJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2431497 | 3000214954 | SKIL-CARE CORP. | 20 Jones Street, STE 2, New Rochelle, NY 10801 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNOAccessories, Wheelchair
- ILDAdaptor, Dressing
- IKXAid, Transfer
- NNWBag, Urine Collection, Leg, For External Use, Non-Sterile
- FNJBed, Manual
- IQBBelt, Wheelchair
- IMXBoard, Lap, Wheelchair
- IODComponents, Exercise
- KICCushion, Flotation
- IMPCushion, Wheelchair
- CBHDevice, Fixation, Tracheal Tube
- FMRDevice, Transfer, Patient, Manual
- IMMFootrest, Wheelchair
- ISAMassager, Therapeutic, Electric
- KMIMonitor, Bed Patient
- FMPProtector, Skin Pressure
- FMQRestraint, Protective
- KIDRestraint, Wheelchair, Non-Protective
- CCXSupport, Patient Position
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain