FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MECHANICAL SHAPE SENSOR
K Number: K913510
·
Decision Sep 23, 1991
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
10
Applicant Total
14
Review Days
47
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MECHANICAL SHAPE SENSOR
- K Number
- K913510
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.1600
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pin Dot Products, Inc.
- Date Received
- August 7, 1991
- Decision Date
- September 23, 1991
- 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
·Physical Medicine
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
COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Pin Dot Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925258 | DYNAMIC PRESSURE MONITOR 2000M AND 2000C | Mar 9, 1993 | Substantially Equivalent |
| K913545 | PIN DOT FLIP-DOWN ABDUCTOR | Sep 5, 1991 | Substantially Equivalent |
| K913507 | ARMREST | Sep 5, 1991 | Substantially Equivalent |
| K913546 | IMPALA CASTERS | Sep 5, 1991 | Substantially Equivalent |
| K913553 | PIN DOT GROWTH/DIAL LINKS | Sep 5, 1991 | Substantially Equivalent |
| K913550 | PIN DOT TRUNION MOUNTS | Sep 5, 1991 | Substantially Equivalent |
| K913549 | PIN DOT MOUNTING BRACKETS | Sep 5, 1991 | Substantially Equivalent |
| K913511 | IMPALA AXLES | Sep 5, 1991 | Substantially Equivalent |
| K913509 | IMPALA WHEELS | Sep 5, 1991 | Substantially Equivalent |
| K913548 | PIN DOT ALUMINUM PAN | Sep 5, 1991 | Substantially Equivalent |