FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIFTON MOBILE PRONE STANDERS
K Number: K921894
·
Decision May 26, 1992
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
65
Applicant Total
7
Review Days
34
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Basic Information
- Device Name
- RIFTON MOBILE PRONE STANDERS
- K Number
- K921894
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3900
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Rifton Equipment For the Handicapped
- Date Received
- April 22, 1992
- Decision Date
- May 26, 1992
- Product Code
- IPL
- 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 |
|---|---|---|---|
| IPL | Wheelchair, Standup | FDA class 2 | Physical Medicine |
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Other Clearances by Rifton Equipment For the Handicapped
| K Number | Device Name | ||
|---|---|---|---|
| K921817 | RIFTON MOR219 19 & RIFTON MOR225 25 | Apr 29, 1992 | Substantially Equivalent |
| K921272 | ACTIVITY CHAIR | Apr 7, 1992 | Substantially Equivalent |
| K892697 | E653 OBLONG ABDUCTION BLOCK | May 9, 1989 | Substantially Equivalent |
| K892698 | E655 ADJUSTABLE ABDUCTION BLOCK W/HIP STABILIZER | May 9, 1989 | Substantially Equivalent |
| K892700 | E65 35 PRONE STANDER | May 9, 1989 | Substantially Equivalent |
| K892699 | E613 PAIR OF SUPPORT BLOCKS | May 9, 1989 | Substantially Equivalent |