Power Scooter, Model TL-688
FDA 510(k) K042010 · Teh Lin Prosthetic & Orthopaedic, Inc.
510(k) numberK042010
Submission
- Device name
- Power Scooter, Model TL-688
- Applicant
- Teh Lin Prosthetic & Orthopaedic, Inc.
Hsin Chu City, TW - Received
- July 26, 2004
- Decision date
- September 1, 2004
- 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 |
|---|---|---|
| K051118 | Model TL-360 Power ScooterINI · Traditional | 05/31/2005SE |
| K051116 | Model TL-560 Power ScooterINI · Traditional | 05/31/2005SE |
| K042012 | Teh Lin Power Scooter, Model TL-822INI · Traditional | 09/24/2004SE |
| K042011 | Power Scooter, Model TL0821INI · Traditional | 09/24/2004SE |
| K041752 | Teh Lin Powered Wheelchair, MDG-601ITI · Traditional | 08/05/2004SE |
| K022696 | Teh Lin Powered Wheelchair, Model MDG-201ITI · Traditional | 02/07/2003SE |
| K022697 | Teh Lin Jupiter Power Chair, Model TL-320ITI · Traditional | 01/24/2003SE |
| K022698 | Scooter Mars Series, Model TL-588INI · Traditional | 12/02/2002SE |
Questions and answers
When was Power Scooter, Model TL-688 cleared by the FDA?
Power Scooter, Model TL-688 (K042010) received a 510(k) decision of Substantially Equivalent on September 1, 2004, 37 days after the submission was received.
What is the product code of K042010?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.