Robo
FDA 510(k) K942508 · Permobil AB
510(k) numberK942508
Submission
- Device name
- Robo
- Applicant
- Permobil AB
Timra, SE - Received
- May 26, 1994
- Decision date
- November 7, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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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| 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.
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|---|---|---|
| K190682 | Explorer MiniIPL · Traditional | 02/27/2020SE |
| K191874 | F5 Corpus VSIPL · Traditional | 10/25/2019SE |
| K143180 | F3ITI · Traditional | 03/27/2015SE |
| K143014 | F5ITI · Traditional | 03/25/2015SE |
| K123290 | M300 & M400ITI · Traditional | 04/17/2013SE |
| K103477 | Permobil M300 / M400ITI · Traditional | 03/03/2011SE |
| K081964 | K450 Powered WheelchairITI · Traditional | 07/29/2008SE |
| K071650 | C350 Powered WheelchairITI · Traditional | 09/12/2007SE |
| K041219 | ElectroITI · Traditional | 08/04/2004SE |
| K032765 | StreetITI · Traditional | 01/30/2004SE |
Questions and answers
When was Robo cleared by the FDA?
Robo (K942508) received a 510(k) decision of Substantially Equivalent for Some Indications on November 7, 1994, 165 days after the submission was received.
What is the product code of K942508?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.