FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)
K Number: K963528
·
Decision Oct 29, 1996
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
133
Applicant Total
11
Review Days
55
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Basic Information
- Device Name
- ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)
- K Number
- K963528
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6760
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alimed, Inc.
- Date Received
- September 4, 1996
- Decision Date
- October 29, 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 |
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Other Clearances by Alimed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963527 | UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS | Oct 31, 1996 | Substantially Equivalent |
| K963526 | STRAP WEDGE | Oct 28, 1996 | Substantially Equivalent |
| K920487 | MINI VIBRATOR | Feb 18, 1992 | Substantially Equivalent |
| K840156 | PROTECTA COAT SPONGES | Mar 23, 1984 | Substantially Equivalent |
| K822650 | SUPER DONUT | Sep 30, 1982 | Substantially Equivalent |
| K822651 | TOTAL FINGER FLEXION SPLINT | Sep 17, 1982 | Substantially Equivalent |
| K820516 | ARTERIAL CANALIZATION DEVICE | Apr 15, 1982 | Substantially Equivalent |
| K820517 | CONSTRUCTA FOAM | Mar 10, 1982 | Substantially Equivalent |
| K801743 | PLASTAZOTE SHOE | Aug 7, 1980 | Substantially Equivalent |
| K791189 | ECHO CARDIOGRAM PAD | Jul 17, 1979 | Substantially Equivalent |