Pro Walker ML-300 Foldable Wheelchair
FDA 510(k) K041337 · Pro Walker, Inc.
510(k) numberK041337
Submission
- Device name
- Pro Walker ML-300 Foldable Wheelchair
- Applicant
- Pro Walker, Inc.
Hsin-Chu City, TW - Received
- May 19, 2004
- Decision date
- May 28, 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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More from Zhenjiang Assure Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K041336 | Pro Walker PL-200 Power WheelchairITI · Traditional | 07/20/2004SE |
Questions and answers
When was Pro Walker ML-300 Foldable Wheelchair cleared by the FDA?
Pro Walker ML-300 Foldable Wheelchair (K041337) received a 510(k) decision of Substantially Equivalent on May 28, 2004, 9 days after the submission was received.
What is the product code of K041337?
The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.