FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
WU'S 3-WHEELED NEO SCOOTER, WT-M4
K Number: K023166
·
Decision Jan 24, 2003
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
327
Applicant Total
21
Review Days
123
Basic Information
- Device Name
- WU'S 3-WHEELED NEO SCOOTER, WT-M4
- K Number
- K023166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- WU'S TECH CO., LTD.
- Date Received
- September 23, 2002
- Decision Date
- January 24, 2003
- Product Code
- INI
- 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 |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | FDA class 2 | Physical Medicine |
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Other Clearances by WU'S TECH CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K091212 | WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H | May 27, 2009 | Substantially Equivalent |
| K082963 | WU'S 4-WHEELED NEO SCOOTER, WT-M3A | Nov 24, 2008 | Substantially Equivalent |
| K072337 | WU'S 4-WHEELED NEO SCOOTER, MODEL WT-M4A | Sep 21, 2007 | Substantially Equivalent |
| K070655 | WU'S POWERED WHEELCHAIR, MAMBO 36 | Apr 2, 2007 | Substantially Equivalent |
| K062790 | WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E | Oct 11, 2006 | Substantially Equivalent |
| K052559 | WU'S POWERED WHEELCHAIR, MAMBO 2 | Sep 26, 2005 | Substantially Equivalent |
| K050042 | WU'S 4-WHEELED NEO SCOOTER, WT-XL4 | Mar 14, 2005 | Substantially Equivalent |
| K050010 | WU'S POWERED WHEELCHAIR, MAMBO 36X | Feb 11, 2005 | Substantially Equivalent |
| K050011 | WU'S POWERED WHEELCHAIR, MAMBO F 120 | Feb 11, 2005 | Substantially Equivalent |
| K040968 | WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D | Apr 30, 2004 | Substantially Equivalent |