Maxima V, Three Wheel Scooter, Model SC900V Maxima V, Four Wheel Scooter, Model SC940V
FDA 510(k) K091113 · Pride Mobility Products Corp.
510(k) numberK091113
Submission
- Device name
- Maxima V, Three Wheel Scooter, Model SC900V Maxima V, Four Wheel Scooter, Model SC940V
- Applicant
- Pride Mobility Products Corp.
Exeter, PA, US - Received
- April 17, 2009
- Decision date
- May 11, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| K090805 | V10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter, Model SC610VPS, V10…INI · Special | 04/03/2009SE |
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| K072165 | Victory Three Wheel Scooter, Model: SC610INI · Special | 08/17/2007SE |
| K071949 | Victory, 4 Wheel Scooter / Model, # SC1740INI · Special | 08/01/2007SE |
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Questions and answers
When was Maxima V, Three Wheel Scooter, Model SC900V Maxima V, Four Wheel Scooter, Model SC940V cleared by the FDA?
Maxima V, Three Wheel Scooter, Model SC900V Maxima V, Four Wheel Scooter, Model SC940V (K091113) received a 510(k) decision of Substantially Equivalent on May 11, 2009, 24 days after the submission was received.
What is the product code of K091113?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.