FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRAFLOTATION BED
K Number: K882607
·
Decision Oct 14, 1988
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
56
Applicant Total
5
Review Days
112
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Basic Information
- Device Name
- ULTRAFLOTATION BED
- K Number
- K882607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5170
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Medical Flotation Systems, Inc.
- Date Received
- June 24, 1988
- Decision Date
- October 14, 1988
- Product Code
- IOQ
- 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 |
|---|---|---|---|
| IOQ | Bed, Flotation Therapy, Powered | FDA class 2 | Physical Medicine |
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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 |
| K884908 | ULTRAFLOTATION MEDICAL WHEELCHAIR | Dec 27, 1988 | Substantially Equivalent |