FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INVACARE 3G TARSYS
K Number: K033819
·
Decision Jun 4, 2004
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
111
Review Days
178
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INVACARE 3G TARSYS
- K Number
- K033819
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Invacare Corp.
- Date Received
- December 9, 2003
- Decision Date
- June 4, 2004
- 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.
Power Wheelchair (W5915B, W5915C, W5915D)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (S500-6)
FDA 510(k)
FDA Class 2
·Physical Medicine
WHILL (WHILL Model C2)
FDA 510(k)
FDA Class 2
·Physical Medicine
Power Wheelchair (N5515A, N5516, N5517A, N5519)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (DF506)
FDA 510(k)
FDA Class 2
·Physical Medicine
Electric Wheelchair (Y207BL)
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Invacare Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K071928 | THE INVACARE FLYER, MODEL IPC 100 | Dec 12, 2007 | Substantially Equivalent |
| K070321 | TWILIGHT FULL FACE MASK | Apr 30, 2007 | Substantially Equivalent |
| K062402 | EASYSTAND EVOLV | Sep 21, 2006 | Substantially Equivalent |
| K061874 | INVACARE'S TWILIGHT II NASAL MASKS | Sep 5, 2006 | 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 |
| K021685 | VENTURE HOMEFILL II WITH OXYGEN CONSERVER | Jul 23, 2002 | Substantially Equivalent |