FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PEDIATRIC TILT CHAIR
K Number: K925272
·
Decision Feb 12, 1993
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
11
Review Days
116
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Basic Information
- Device Name
- PEDIATRIC TILT CHAIR
- K Number
- K925272
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Labac Systems, Inc.
- Date Received
- October 19, 1992
- Decision Date
- February 12, 1993
- 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 Labac Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941157 | BASIC RECLINE CHAIR | Apr 7, 1994 | Substantially Equivalent |
| K934418 | BASIC TILT CHAIR ( BTC ) | Jan 7, 1994 | Substantially Equivalent |
| K932639 | MANUAL TILT RECLINE CHAIR (MTC) | Jul 22, 1993 | Substantially Equivalent |
| K923362 | REDUCED SHEAR OWR RECLINE SYSTEM | Mar 26, 1993 | Substantially Equivalent |
| K923363 | ADJUSTABLE SLIDING BACK POWER RECLINE SYSTEM | Mar 24, 1993 | Substantially Equivalent |
| K921028 | MANUAL RECLINING CHAIR | Mar 24, 1993 | Substantially Equivalent |
| K923364 | TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST | Mar 22, 1993 | Substantially Equivalent |
| K923366 | TILT SEATING SYSTEM | Feb 12, 1993 | Substantially Equivalent |
| K921136 | MANUAL TILT CHAIR | Apr 2, 1992 | Substantially Equivalent |
| K921027 | MANUAL CHAIR BASE | Mar 20, 1992 | Substantially Equivalent |