FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPINAL TOUCH
K Number: K961212
·
Decision Jun 12, 1996
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
32
Applicant Total
9
Review Days
76
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Basic Information
- Device Name
- SPINAL TOUCH
- K Number
- K961212
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.1500
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fasstech
- Date Received
- March 28, 1996
- Decision Date
- June 12, 1996
- Product Code
- KQX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| KQX | Goniometer, Ac-Powered | FDA class 1 | Orthopedic |
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Other Clearances by Fasstech
| K Number | Device Name | ||
|---|---|---|---|
| K063447 | INSIGHT DISCOVERY | Aug 16, 2007 | Substantially Equivalent |
| K033452 | CWAS 1000 | Nov 28, 2003 | Substantially Equivalent |
| K023209 | INSIGHT MILLENNIUM III | Oct 10, 2003 | Substantially Equivalent |
| K011964 | INSIGHT MILLENNIUM PLUS | Sep 20, 2001 | Substantially Equivalent |
| K011983 | INSIGHT GENESIS | Aug 30, 2001 | Substantially Equivalent |
| K990778 | INSIGHT MILLENNIUM | Jun 3, 1999 | Substantially Equivalent |
| K940050 | FOCUS EMG | Feb 24, 1995 | Substantially Equivalent |
| K925197 | PSI 220 DUAL EMG | Feb 2, 1993 | Substantially Equivalent |