FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
2P-QDA FOOT PRESSURE SYSTEMS REAL TIME
K Number: K882139
·
Decision Jun 22, 1988
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
10
Applicant Total
2
Review Days
30
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Basic Information
- Device Name
- 2P-QDA FOOT PRESSURE SYSTEMS REAL TIME
- K Number
- K882139
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.1600
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Human Performance Technologies, Inc.
- Date Received
- May 23, 1988
- Decision Date
- June 22, 1988
- Product Code
- JFC
- 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 |
|---|---|---|---|
| JFC | System, Pressure Measurement, Intermittent | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JFC), ordered by most recent decision date.
FORCE SENSING ARRAY
FDA 510(k)
FDA Class 1
·Physical Medicine
QA PRESSURE MEASUREMENT SYSTEM
FDA 510(k)
FDA Class 1
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DYNAMIC PRESSURE MONITOR 2000M AND 2000C
FDA 510(k)
FDA Class 1
·Physical Medicine
CDG GAIT ANALYSES SYSTEM
FDA 510(k)
FDA Class 1
·Physical Medicine
OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR
FDA 510(k)
FDA Class 1
·Physical Medicine
MECHANICAL SHAPE SENSOR
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Human Performance Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880631 | 2K-QDA MOTION/GAIT ANALYSIS SYSTEM | Apr 21, 1988 | Substantially Equivalent |