FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POIRIER KID-ROLLER MANUAL WHEELCHAIR
K Number: K874317
·
Decision Nov 17, 1987
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
24
Review Days
27
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Basic Information
- Device Name
- POIRIER KID-ROLLER MANUAL WHEELCHAIR
- K Number
- K874317
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Roseburg SA
- Date Received
- October 21, 1987
- Decision Date
- November 17, 1987
- 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
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ICON 35; ICON 45; ICON 60; ICON 30FAF
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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
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| K Number | Device Name | ||
|---|---|---|---|
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| K885275 | ASSENAT-BLESCHET SUNGLASSES | Jan 24, 1989 | Substantially Equivalent |
| K882392 | BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES | Aug 26, 1988 | Substantially Equivalent |
| K872715 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | Dec 7, 1987 | Substantially Equivalent for Some Indications |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | Jul 21, 1987 | Substantially Equivalent |
| K871688 | SPECTACLE FRAME - DANIELLE | May 29, 1987 | Substantially Equivalent |
| K871689 | SPECTACLE FRAME - LORRAINE | May 29, 1987 | Substantially Equivalent |
| K870654 | EFER ARTHROSCOPE | May 14, 1987 | Substantially Equivalent |
| K864436 | STAVIP 3000 | Mar 16, 1987 | Substantially Equivalent |