FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRAFLOTATION MEDICAL WHEELCHAIR
K Number: K884908
·
Decision Dec 27, 1988
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
4
Applicant Total
5
Review Days
34
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Basic Information
- Device Name
- ULTRAFLOTATION MEDICAL WHEELCHAIR
- K Number
- K884908
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3940
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Medical Flotation Systems, Inc.
- Date Received
- November 23, 1988
- Decision Date
- December 27, 1988
- Product Code
- INF
- 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 |
|---|---|---|---|
| INF | Scale, Platform, Wheelchair | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (INF), ordered by most recent decision date.
U.S. MEDICAL PS-6000 WHEELCHAIR SCALE
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ACME MODEL 8500 WHEELCHAIR SCALE
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AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)
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FDA Class 1
·Physical Medicine
WHEEL'N WEIGH
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Medical Flotation Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K893801 | M.F.S. LOW AIR LOSS PULSATING BED | Jul 25, 1989 | Substantially Equivalent |
| K890200 | PNEUMATIC DORSIFLEXOR | Feb 3, 1989 | Substantially Equivalent |
| K884907 | BUMPY MEDICAL MASSAGE MAT | Dec 27, 1988 | Substantially Equivalent |
| K882607 | ULTRAFLOTATION BED | Oct 14, 1988 | Substantially Equivalent |