PCE — Permanently Mounted Wheelchair Platform Lift Class II
FDA product code PCE covers "Permanently Mounted Wheelchair Platform Lift", a Class II medical device regulated under 21 CFR 890.3930. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PCE
- Device Class
- Class II
- Regulation Number
- 890.3930
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
Intended for medical purposes to provide a guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K122206 | garaventa (canada) ltd [dba garaventa lift] | GARAVENTA X3 INCLINED PLATFORM LIFT | March 21, 2013 |