Jazzy Elite 6
FDA 510(k) K113488 · Pride Mobility Product Corporration
510(k) numberK113488
Submission
- Device name
- Jazzy Elite 6
- Applicant
- Pride Mobility Product Corporration
Exeter, PA, US - Received
- November 23, 2011
- Decision date
- April 18, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
More from Whill, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K112815 | Quantum Bariatric 451ITI · Special | 02/29/2012SE |
Questions and answers
When was Jazzy Elite 6 cleared by the FDA?
Jazzy Elite 6 (K113488) received a 510(k) decision of Substantially Equivalent on April 18, 2012, 147 days after the submission was received.
What is the product code of K113488?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.