FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MINI VIBRATOR
K Number: K920487
·
Decision Feb 18, 1992
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
64
Applicant Total
11
Review Days
19
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Basic Information
- Device Name
- MINI VIBRATOR
- K Number
- K920487
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5975
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alimed, Inc.
- Date Received
- January 30, 1992
- Decision Date
- February 18, 1992
- Product Code
- IRO
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IRO | Vibrator, Therapeutic | FDA class 1 | Physical Medicine |
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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 |
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| K963526 | STRAP WEDGE | Oct 28, 1996 | 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 |