FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
K Number: K090108
·
Decision Mar 19, 2009
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
580
Applicant Total
17
Review Days
63
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Basic Information
- Device Name
- HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
- K Number
- K090108
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hoveround Corp.
- Date Received
- January 15, 2009
- Decision Date
- March 19, 2009
- 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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Other Clearances by Hoveround Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K122707 | HOVERROUND TEKNIQUE | May 7, 2013 | Substantially Equivalent |
| K122741 | HOVEROUND TEKNIQUE | May 7, 2013 | Substantially Equivalent |
| K100527 | HOVEROUND TEKNIQUE, MODEL HD-6 | Mar 26, 2010 | Substantially Equivalent |
| K093946 | HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 | Mar 22, 2010 | Substantially Equivalent |
| K100350 | HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT | Mar 22, 2010 | Substantially Equivalent |
| K042920 | HOVEROUND SE-3 POWERCHAIR | Dec 3, 2004 | Substantially Equivalent |
| K043069 | HOVEROUND E100 POWER CHAIR | Dec 3, 2004 | Substantially Equivalent |
| K042545 | HOVEROUND MPV-5 POWERCHAIR | Oct 21, 2004 | Substantially Equivalent |
| K042033 | HOVEROUND POWER WHEELCHAIR, MODEL HD700 | Sep 29, 2004 | Substantially Equivalent |
| K022993 | HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS | Dec 2, 2002 | Substantially Equivalent |