FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL CONTACT SEAT RIPPLE SYSTEM
K Number: K943433
·
Decision Jul 31, 1995
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
56
Applicant Total
2
Review Days
381
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Basic Information
- Device Name
- TOTAL CONTACT SEAT RIPPLE SYSTEM
- K Number
- K943433
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5170
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Numotech, Inc.
- Date Received
- July 15, 1994
- Decision Date
- July 31, 1995
- 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 Numotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981949 | NUMOBAG | Feb 3, 1999 | Substantially Equivalent |