Comfort Scooter Model LY-EW406
FDA 510(k) K063030 · Comfort Orthopedic Co., Ltd.
510(k) numberK063030
Submission
- Device name
- Comfort Scooter Model LY-EW406
- Applicant
- Comfort Orthopedic Co., Ltd.
Hsin-Chu City, TW - Received
- October 3, 2006
- Decision date
- December 4, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- INI – Vehicle, Motorized 3-Wheeled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3800
- Specialty
- Physical Medicine
Other 510(k)s with product code INI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260176 | Mobility Scooter (W3483, W3483A)INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon))INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K261232 | IERO Mobility Scooter (IERO-01)INI · Traditional | Jochu Technology Co., Ltd. | 07/14/2026SE |
| K261163 | Mobility Scooter (R200)INI · Traditional | Yongkang Ruihe Metal Product Co., Ltd. | 07/07/2026SE |
| K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F)INI · Traditional | Jiangsu Intco Medical Products Co., Ltd. | 06/08/2026SE |
| K253600 | Scooter (YD-03)INI · Traditional | Yurob Rehabilitation Medical Co., Ltd. | 06/03/2026SE |
| K260717 | Mobility Scooter (Air Carbon)INI · Traditional | Suzhou Sweetrich Vehicle Industry Technology… | 05/20/2026SE |
| K260237 | Mobility Scooter (X-12, X-14, X-17)INI · Traditional | Wuyi Aichi Industry and Trade Co., Ltd. | 04/22/2026SE |
| K252813 | Electrical Scooter (SM4226)INI · Traditional | Lerado Zhongshan Peaceful Cove Business Trading… | 03/17/2026SE |
| K253936 | Power Mobility Scooter (MJMA01, MJMA02)INI · Traditional | Nanjing Mijo Technology Co., Ltd. | 03/12/2026SE |
More from Nanjing Mijo Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K102734 | Comfort Standing Wheelchair, Hero SeriesIPL · Traditional | 12/14/2010SE |
| K072712 | Comfort Electric Scooter, LY-EW408INI · Traditional | 10/31/2007SE |
| K072711 | Comfort Powered Wheelchair, Ly-Eb 206ITI · Traditional | 10/31/2007SE |
| K063032 | Comfort Scooter, Model LY-EW415INI · Traditional | 10/16/2006SE |
| K031621 | Hero 1, Model LY-ESB220IPL · Traditional | 01/22/2004SE |
| K031618 | Comfort Various of Standing Wheelchair, Hero 2IPL · Traditional | 12/18/2003SE |
| K030356 | Comfort Powered Wheelchair, Traveller Ly-Eb 103ITI · Traditional | 05/20/2003SE |
| K030355 | Comfort Powered Wheelchair, Conqueror Ly-Eb 202ITI · Traditional | 05/20/2003SE |
| K023581 | Comfort Agile Scooter, LY-EW303INI · Traditional | 12/02/2002SE |
| K022369 | Comfort Windjoy Scooter, Model LY-EW302INI · Traditional | 10/11/2002SE |
Questions and answers
When was Comfort Scooter Model LY-EW406 cleared by the FDA?
Comfort Scooter Model LY-EW406 (K063030) received a 510(k) decision of Substantially Equivalent on December 4, 2006, 62 days after the submission was received.
What is the product code of K063030?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.