FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMPALA
K Number: K913512
·
Decision Aug 29, 1991
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
14
Review Days
22
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Basic Information
- Device Name
- IMPALA
- K Number
- K913512
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pin Dot Products, Inc.
- Date Received
- August 7, 1991
- Decision Date
- August 29, 1991
- Product Code
- IOR
- 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
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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 |
| K913510 | MECHANICAL SHAPE SENSOR | Sep 23, 1991 | 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 |