FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.
K Number: K994107
·
Decision Jan 13, 2000
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
3
Review Days
38
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Basic Information
- Device Name
- AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.
- K Number
- K994107
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Amylior, Inc.
- Date Received
- December 6, 1999
- Decision Date
- January 13, 2000
- Product Code
- ITI
- 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 |
|---|---|---|---|
| ITI | Wheelchair, Powered | FDA class 2 | Physical Medicine |
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