Esg 4-WHEEL Scooter, ESG-03
FDA 510(k) K033204 · Emg Technology Co., Ltd.
510(k) numberK033204
Submission
- Device name
- Esg 4-WHEEL Scooter, ESG-03
- Applicant
- Emg Technology Co., Ltd.
Hsin-Chu City, TW - Received
- October 2, 2003
- Decision date
- November 12, 2003
- 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 |
|---|---|---|
| K112421 | Emg Suction UnitJCX · Traditional | 09/01/2011SE |
| K072634 | Emg Triton -Comp,Model NCA01-XXX SeriesBTI · Traditional | 11/19/2008SE |
| K063448 | Emg Ac/Dc Suction UnitJCX · Traditional | 11/30/2006SE |
| K062888 | Middle Wheel Drive Power Chair, CWD01ITI · Traditional | 10/24/2006SE |
| K052438 | Emg Handle Nebulizer NB02 SeriesCAF · Abbreviated | 01/31/2006SE |
| K043520 | Emg CTA01-XXX Series Puro Oxygen ConcentratorCAW · Abbreviated | 10/21/2005SE |
| K043238 | Compressor Nebulizer, Model Emg NBA02-XXX SeriesCAF · Abbreviated | 07/06/2005SE |
| K042349 | Emg Model SUA01 Suction UnitJCX · Abbreviated | 12/16/2004SE |
| K033206 | Epw Foldable Power Wheelchair, EPW-03ITI · Traditional | 12/18/2003SE |
| K023148 | Epw Powered Wheelchair, GP-201ITI · Traditional | 01/24/2003SE |
Questions and answers
When was Esg 4-WHEEL Scooter, ESG-03 cleared by the FDA?
Esg 4-WHEEL Scooter, ESG-03 (K033204) received a 510(k) decision of Substantially Equivalent on November 12, 2003, 41 days after the submission was received.
What is the product code of K033204?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.