FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RESTRAINT ACCESSORIES
K Number: K963436
·
Decision Nov 22, 1996
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
133
Applicant Total
13
Review Days
84
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Basic Information
- Device Name
- RESTRAINT ACCESSORIES
- K Number
- K963436
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6760
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- J. T. Posey Co.
- Date Received
- August 30, 1996
- Decision Date
- November 22, 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.
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STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
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CENTURION PROTECTIVE RESTRAINT, SCR SERIES
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COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
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INFANT LIMB HOLDER, MODELS 306080 & 306081
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CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
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Other Clearances by J. T. Posey Co.
| K Number | Device Name | ||
|---|---|---|---|
| K113355 | POSEY BED | May 2, 2012 | Substantially Equivalent |
| K113357 | POSEY BED | Mar 21, 2012 | Substantially Equivalent |
| K103817 | POSEY BED | Apr 22, 2011 | Substantially Equivalent |
| K963414 | MULTIPLE BELTS | Nov 22, 1996 | Substantially Equivalent |
| K963410 | POSEY STRAIGHT JACKETS | Nov 22, 1996 | Substantially Equivalent |
| K963442 | JACKETS AND VESTS | Nov 22, 1996 | Substantially Equivalent |
| K963439 | PEDIATRIC LIMB HOLDERS | Nov 19, 1996 | Substantially Equivalent |
| K963437 | PELVIC HOLDERS | Nov 19, 1996 | Substantially Equivalent |
| K963411 | POSEY LAPTOP TRAYS | Nov 19, 1996 | Substantially Equivalent |
| K963413 | MULTIPLE LIMB HOLDERS | Nov 14, 1996 | Substantially Equivalent |