M300 & M400
FDA 510(k) K123290 · Permobil AB
510(k) numberK123290
Submission
- Device name
- M300 & M400
- Applicant
- Permobil AB
Timra, SE - Received
- October 22, 2012
- Decision date
- April 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ITI – Wheelchair, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3860
- Specialty
- Physical Medicine
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type…
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| K253812 | Power Wheelchair (W5915B, W5915C, W5915D)ITI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 06/18/2026SE |
| K260335 | Electric Wheelchair (S500-6)ITI · Traditional | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 06/15/2026SE |
| K261175 | WHILL (WHILL Model C2)ITI · Traditional | Whill, Inc. | 06/12/2026SE |
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|---|---|---|
| K190682 | Explorer MiniIPL · Traditional | 02/27/2020SE |
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| K143180 | F3ITI · Traditional | 03/27/2015SE |
| K143014 | F5ITI · Traditional | 03/25/2015SE |
| 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 |
| K993406 | Trax, Powered Wheelchair, Model 308686-00-0ITI · Abbreviated | 12/18/2000SE |
Questions and answers
When was M300 & M400 cleared by the FDA?
M300 & M400 (K123290) received a 510(k) decision of Substantially Equivalent on April 17, 2013, 177 days after the submission was received.
What is the product code of K123290?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.