FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROLL BELT
K Number: K963460
·
Decision Oct 9, 1996
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
133
Applicant Total
20
Review Days
36
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Basic Information
- Device Name
- ROLL BELT
- K Number
- K963460
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6760
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Skil-Care Corp.
- Date Received
- September 3, 1996
- Decision Date
- October 9, 1996
- Product Code
- FMQ
- 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 |
|---|---|---|---|
| FMQ | Restraint, Protective | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMQ), ordered by most recent decision date.
PROTECTIVE RESTRAINT
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FDA Class 1
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STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
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FDA Class 1
·General Hospital
CENTURION PROTECTIVE RESTRAINT, SCR SERIES
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FDA Class 1
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COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
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FDA Class 1
·General Hospital
INFANT LIMB HOLDER, MODELS 306080 & 306081
FDA 510(k)
FDA Class 1
·General Hospital
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
FDA 510(k)
FDA Class 1
·General Hospital
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 |
| 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 |
| K963448 | ECONO BELT | Oct 7, 1996 | Substantially Equivalent |