FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM
K Number: K883198
·
Decision Oct 24, 1988
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
14
Applicant Total
5
Review Days
88
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Basic Information
- Device Name
- BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEM
- K Number
- K883198
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.1575
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Advanced Mechanical Technology, Inc.
- Date Received
- July 28, 1988
- Decision Date
- October 24, 1988
- Product Code
- KHX
- 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 |
|---|---|---|---|
| KHX | Platform, Force-Measuring | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHX), ordered by most recent decision date.
COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM
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BALANCE MANAGER
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STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302
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SMS BALANCE PERFORMANCE MONITOR
FDA 510(k)
FDA Class 1
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FORCE MEASURING PLATFORM
FDA 510(k)
FDA Class 1
·Physical Medicine
COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Advanced Mechanical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883130 | BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000 | Oct 24, 1988 | Substantially Equivalent |
| K883131 | BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000 | Oct 24, 1988 | Substantially Equivalent |
| K883129 | BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000 | Oct 24, 1988 | Substantially Equivalent |
| K883127 | MULTI-CHANNEL STRAIN-GAGE AMPLIFIER & POWER SUPPLY | Sep 30, 1988 | Substantially Equivalent |