FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500
K Number: K992627
·
Decision Oct 25, 1999
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
8
Review Days
81
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Basic Information
- Device Name
- FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500
- K Number
- K992627
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teftec Corp.
- Date Received
- August 5, 1999
- Decision Date
- October 25, 1999
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITI), ordered by most recent decision date.
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Electric Wheelchair (Y207BL)
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Other Clearances by Teftec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K022652 | ALPHATRAC, MODEL A 205 | Nov 21, 2002 | Substantially Equivalent |
| K013307 | OMEGATRAC, MODEL Z105 | Feb 8, 2002 | Substantially Equivalent |
| K993160 | OMEGA TRAC, MODEL Z100 | Nov 18, 1999 | Substantially Equivalent |
| K992628 | FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400 | Oct 25, 1999 | Substantially Equivalent |
| K983066 | FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300 | Nov 27, 1998 | Substantially Equivalent |
| K982815 | ALPHATRAC, MODEL A200 | Nov 6, 1998 | Substantially Equivalent |
| K955240 | OMEGATRAC BY TEFTEC | Jul 1, 1996 | Substantially Equivalent |