FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WHEELCHAIR MECHANICAL
K Number: K840024
·
Decision Jan 30, 1984
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
32
Review Days
25
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Basic Information
- Device Name
- WHEELCHAIR MECHANICAL
- K Number
- K840024
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Amico Lab, Inc.
- Date Received
- January 5, 1984
- Decision Date
- January 30, 1984
- Product Code
- IOR
- 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IOR), ordered by most recent decision date.
ICON 35; ICON 45; ICON 60; ICON 30FAF
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Manual Wheelchair (DY01903(2))
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Manual Wheelchair (7101L, 7102LHD)
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K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Amico Lab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K842662 | ANTI-EPSTEIN-BARR VIRUS KIT | Dec 12, 1985 | Substantially Equivalent |
| K842530 | AMIZYME-EBV TEST KIT | Dec 6, 1985 | Substantially Equivalent |
| K842663 | ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 | Dec 6, 1985 | Substantially Equivalent |
| K842531 | AMIZYME-HSV TYPES 1 & 2 TEST KITS | Dec 6, 1985 | Substantially Equivalent |
| K842529 | AMIZYME-CMV KIT | Dec 6, 1985 | Substantially Equivalent |
| K842661 | ANTI-CYTOMEGALOVIRUS KIT | Dec 6, 1985 | Substantially Equivalent |
| K842660 | ANTI-SCHISTOSOMA SPECIES KIT | Oct 30, 1984 | Substantially Equivalent |
| K842658 | ANTI-CHLAMYDIA TRACHOMATIS KIT | Oct 1, 1984 | Substantially Equivalent |
| K842525 | AMIZYME-C TRACHOMATIS TEST KIT | Oct 1, 1984 | Substantially Equivalent |
| K842532 | AMIZYME-ANA TEST KIT | Sep 20, 1984 | Substantially Equivalent |