FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRUISER
K Number: K854164
·
Decision Jan 13, 1986
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
550
Applicant Total
111
Review Days
90
Basic Information
- Device Name
- CRUISER
- K Number
- K854164
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- INVACARE CORP.
- Date Received
- October 15, 1985
- Decision Date
- January 13, 1986
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K062402 | EASYSTAND EVOLV | Sep 21, 2006 | Substantially Equivalent |
| K061874 | INVACARE'S TWILIGHT II NASAL MASKS | Sep 5, 2006 | Substantially Equivalent |
| K033819 | INVACARE 3G TARSYS | Jun 4, 2004 | Substantially Equivalent |
| K031176 | INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 | Mar 25, 2004 | Substantially Equivalent |
| K031064 | INVACARE POLARIS EX CPAP, MODEL ISP3000 | Mar 12, 2004 | Substantially Equivalent |
| K030814 | INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3 | Mar 20, 2003 | Substantially Equivalent |
| K022642 | TWLIGHT, MODEL ISP 9600 | Feb 11, 2003 | Substantially Equivalent |
| K023589 | STORM TDX POWER WHEELCHAIR | Nov 19, 2002 | Substantially Equivalent |