Victory Three Wheel Scooter, Model: SC610
FDA 510(k) K072165 · Pride Mobility Products Corp.
510(k) numberK072165
Submission
- Device name
- Victory Three Wheel Scooter, Model: SC610
- Applicant
- Pride Mobility Products Corp.
Exeter, PA, US - Received
- August 6, 2007
- Decision date
- August 17, 2007
- 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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Questions and answers
When was Victory Three Wheel Scooter, Model: SC610 cleared by the FDA?
Victory Three Wheel Scooter, Model: SC610 (K072165) received a 510(k) decision of Substantially Equivalent on August 17, 2007, 11 days after the submission was received.
What is the product code of K072165?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.