FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS
K Number: K981837
·
Decision Jul 9, 1998
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
9
Review Days
44
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Basic Information
- Device Name
- TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS
- K Number
- K981837
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Motion Concepts
- Date Received
- May 26, 1998
- Decision Date
- July 9, 1998
- 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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Other Clearances by Motion Concepts
| K Number | Device Name | ||
|---|---|---|---|
| K191376 | Modular Power Standing System | Aug 13, 2019 | Substantially Equivalent |
| K182995 | Bariatric Power Positioning System (BPPS) | Mar 8, 2019 | Substantially Equivalent |
| K150574 | Modular Power Positioning System | Jun 30, 2015 | Substantially Equivalent |
| K023426 | TRX VERTICAL POSITIONER | Nov 21, 2002 | Substantially Equivalent |
| K021264 | TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND POWER ELEVATING SEAT | Jul 30, 2002 | Substantially Equivalent |
| K994241 | TRX-CG POWER TILT AND RECLINE SYSTEM | Jan 13, 2000 | Substantially Equivalent |
| K990544 | TRX-CG POWER TILT AND RECLINE SYSTEM | Apr 8, 1999 | Substantially Equivalent |
| K970521 | TRX POWER TILT AND RECLINE SYSTEM | Mar 31, 1997 | Substantially Equivalent |