FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SKIL-CARE BED RAIL PADS
K Number: K791993
·
Decision Oct 26, 1979
Classifications
1
FEI Numbers
221
Registration Numbers
221
Same Product Code
38
Applicant Total
20
Review Days
23
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Basic Information
- Device Name
- SKIL-CARE BED RAIL PADS
- K Number
- K791993
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5120
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Skil-Care Corp.
- Date Received
- October 3, 1979
- Decision Date
- October 26, 1979
- Product Code
- FNJ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FNJ | Bed, Manual | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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MSI STANDARD BED MODELS: L1097-64 AND L1085-64
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Other Clearances by Skil-Care Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K010818 | INFANT LIMB HOLDER, MODELS 306080 & 306081 | May 24, 2001 | Substantially Equivalent |
| K010644 | CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 | May 18, 2001 | Substantially Equivalent |
| K963458 | PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS | Oct 18, 1996 | Substantially Equivalent |
| K963459 | SUPPORT VEST | Oct 15, 1996 | Substantially Equivalent |
| K963461 | SAFETY PONCHO/SHOULDER STRAP PONCHO | Oct 11, 1996 | Substantially Equivalent |
| K963457 | SLEEPER JACKET/HOUDINI SAFETY SLEEPER | Oct 9, 1996 | Substantially Equivalent |
| K963460 | ROLL BELT | Oct 9, 1996 | Substantially Equivalent |
| K963455 | SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL | Oct 8, 1996 | Substantially Equivalent |
| K963456 | LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER | Oct 8, 1996 | Substantially Equivalent |
| K963447 | DOUBLE SUPPORT PONCHO/SLIDER PONCHO | Oct 7, 1996 | Substantially Equivalent |