Booster Lite 3 Motorized Scooter
FDA 510(k) K955274 · Optimed Technologies, Inc.
510(k) numberK955274
Submission
- Device name
- Booster Lite 3 Motorized Scooter
- Applicant
- Optimed Technologies, Inc.
Washington, DC, US - Received
- November 15, 1995
- Decision date
- November 4, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K972520 | OptiviewLLZ · Traditional | 09/29/1997SE |
| K955276 | Booster Lite 4 Motorized ScooterINI · Traditional | 11/04/1996SE |
| K955275 | Booster Trophy 5 Motorized ScooterINI · Traditional | 11/04/1996SE |
| K943598 | Flexible Fiber Optic LaparoscopesHET · Traditional | 10/18/1994SE |
| K926597 | Laparoscope, Gynecologic (and Accessories)HET · Traditional | 07/12/1994SE |
| K921942 | Hysteroscope (and Accessories)HIH · Traditional | 06/24/1994SE |
| K922711 | Flexible Fiber Optic Gynecologic EndoscopeHIH · Traditional | 05/17/1994SE |
| K921985 | Arthroscope & AccessoriesHRX · Traditional | 06/29/1993SE |
| K922826 | Flexible Fiber Optic EndoscopeFGA · Traditional | 02/19/1993SE |
| K921883 | EndoscopeGCM · Traditional | 11/23/1992SE |
Questions and answers
When was Booster Lite 3 Motorized Scooter cleared by the FDA?
Booster Lite 3 Motorized Scooter (K955274) received a 510(k) decision of Substantially Equivalent on November 4, 1996, 355 days after the submission was received.
What is the product code of K955274?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.