Hoverround Teknique
FDA 510(k) K122707 · Hoveround Corp.
510(k) numberK122707
Submission
- Device name
- Hoverround Teknique
- Applicant
- Hoveround Corp.
Sarasota, FL, US - Received
- September 4, 2012
- Decision date
- May 7, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K260229 | Electric wheelchair (HC819N, HC830N, HC831N)ITI · Traditional | Yongkang Hengyi Vehicle Co., Ltd. | 09/08/2026SE |
| K260053 | Power Wheelchair (OS-R-M01I)ITI · Traditional | Beijing OrionStar Technology Co., Ltd. | 09/08/2026SE |
| K261354 | Electric wheelchair (D03)ITI · Traditional | Foshan Sowell Medical Technology Co., Ltd. | 08/21/2026SE |
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| K261396 | Electric WheelchairITI · Traditional | Ningbo Resshidi Medical Devices Co., Ltd. | 07/08/2026SE |
| K261164 | Electric wheelchair (XW-LY007 )ITI · Traditional | Yongkang Ruihe Metal Product Co., Ltd. | 07/07/2026SE |
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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 |
More from Whill, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K122741 | Hoveround TekniqueITI · Traditional | 05/07/2013SE |
| K100527 | Hoveround Teknique, Model HD-6ITI · Special | 03/26/2010SE |
| K100350 | Hoveround Teknique GT Power Wheelchair, Model# Teknique GTITI · Traditional | 03/22/2010SE |
| K093946 | Hoveround Hoverglide Model Hoverglide MK-2ILK · Traditional | 03/22/2010SE |
| K090108 | Hoveround Teknique FWD MK4 Power WheelchairITI · Traditional | 03/19/2009SE |
| K043069 | Hoveround E100 Power ChairITI · Traditional | 12/03/2004SE |
| K042920 | Hoveround SE-3 PowerchairITI · Traditional | 12/03/2004SE |
| K042545 | Hoveround MPV-5 PowerchairITI · Traditional | 10/21/2004SE |
| K042033 | Hoveround Power Wheelchair, Model HD700ITI · Traditional | 09/29/2004SE |
| K022993 | Hoveround Rehab Seating System for Power WheelchairsITI · Traditional | 12/02/2002SE |
Questions and answers
When was Hoverround Teknique cleared by the FDA?
Hoverround Teknique (K122707) received a 510(k) decision of Substantially Equivalent on May 7, 2013, 245 days after the submission was received.
What is the product code of K122707?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.