FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REDUCED SHEAR OWR RECLINE SYSTEM
K Number: K923362
·
Decision Mar 26, 1993
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
11
Review Days
261
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Basic Information
- Device Name
- REDUCED SHEAR OWR RECLINE SYSTEM
- K Number
- K923362
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Labac Systems, Inc.
- Date Received
- July 8, 1992
- Decision Date
- March 26, 1993
- 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
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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 |
| 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 |
| K925272 | PEDIATRIC TILT CHAIR | Feb 12, 1993 | Substantially Equivalent |
| K921136 | MANUAL TILT CHAIR | Apr 2, 1992 | Substantially Equivalent |
| K921027 | MANUAL CHAIR BASE | Mar 20, 1992 | Substantially Equivalent |