Litestream 500E
FDA 510(k) K042444 · Pride Mobility Products Corp.
510(k) numberK042444
Submission
- Device name
- Litestream 500E
- Applicant
- Pride Mobility Products Corp.
Exeter, PA, US - Received
- September 9, 2004
- Decision date
- October 21, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K260849 | Icon 35; Icon 45; Icon 60; Icon 30FAFIOR · Traditional | Rehasense USA, Inc. | 06/11/2026SE |
| K260642 | Manual Wheelchair (LW01108)IOR · Traditional | Anhui Longway Medical Technology Co., Ltd. | 06/02/2026SE |
| K260295 | Helio Kids; Apex PIOR · Traditional | Motion Composites | 05/28/2026SE |
| K254141 | Manual Wheelchair (DY01903(2))IOR · Traditional | Guangdong Dayang Medical Technology Co., Ltd. | 05/21/2026SE |
| 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 |
|---|---|---|
| K111739 | Kids Rock 3 ChairIOR · Special | 08/12/2011SE |
| K091578 | Lift Chair, Model T3INO · Special | 12/02/2009SE |
| K092961 | Jazzy FrontieITI · Special | 10/23/2009SE |
| K092088 | Victory XL 130 Four Wheel Scooter, Model SC713INI · Special | 07/16/2009SE |
| K091113 | Maxima V, Three Wheel Scooter, Model SC900V Maxima V, Four Wheel Scooter, Model SC940VINI · Special | 05/11/2009SE |
| K090805 | V10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter, Model SC610VPS, V10…INI · Special | 04/03/2009SE |
| K090524 | Go Go Elite Traveler V Three Wheel Scooter, Model SC40EVINI · Special | 03/19/2009SE |
| K072165 | Victory Three Wheel Scooter, Model: SC610INI · Special | 08/17/2007SE |
| K071949 | Victory, 4 Wheel Scooter / Model, # SC1740INI · Special | 08/01/2007SE |
| K070950 | Lift Chair, Model C5INO · Special | 04/16/2007SE |
Questions and answers
When was Litestream 500E cleared by the FDA?
Litestream 500E (K042444) received a 510(k) decision of Substantially Equivalent on October 21, 2004, 42 days after the submission was received.
What is the product code of K042444?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.