Tilite Aero X
FDA 510(k) K072311 · Tisport, LLC
510(k) numberK072311
Submission
- Device name
- Tilite Aero X
- Applicant
- Tisport, LLC
Kennewick, WA, US - Received
- August 17, 2007
- Decision date
- September 21, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IOR – Wheelchair, Mechanical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3850
- Specialty
- Physical Medicine
A mechanical wheelchair is a manually 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/or require an assistive device for mobility.
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| K260642 | Manual Wheelchair (LW01108)IOR · Traditional | Anhui Longway Medical Technology Co., Ltd. | 06/02/2026SE |
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| K260121 | Manual Wheelchair (7101L, 7102LHD)IOR · Traditional | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 04/28/2026SE |
| K260319 | K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with…IOR · Traditional | Zhenjiang Assure Medical Equipment Co., Ltd. | 03/31/2026SE |
More from Zhenjiang Assure Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K024055 | Tilite EvoIOR · Traditional | 12/20/2002SE |
| K023606 | Tilite Yg and Tilite YgsIOR · Traditional | 11/19/2002SE |
| K020639 | Tipower TR Rimpower and Tipower Tra RimpowerITI · Traditional | 06/20/2002SE |
| K020539 | Tipower Powerdrive and Rimpower X & SXITI · Traditional | 06/20/2002SE |
| K990555 | Tisport X and Tisport XCIOR · Traditional | 03/22/1999SE |
| K990358 | Cross Sport, Rigid WheelchairIOR · Traditional | 02/26/1999SE |
Questions and answers
When was Tilite Aero X cleared by the FDA?
Tilite Aero X (K072311) received a 510(k) decision of Substantially Equivalent on September 21, 2007, 35 days after the submission was received.
What is the product code of K072311?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.