510(k) K073513
K073513 is an FDA 510(k) premarket notification submitted by Merits Health Products Co., Ltd. for the device "MERITS E700 PORCE LIFT". The FDA issued a decision of Substantially Equivalent on January 14, 2008. The device falls under product code ING (Elevator, Wheelchair, Portable), a Class II device regulated under 21 CFR 890.3930. Merits Health Products Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2008
- Date Received
- December 14, 2007
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Elevator, Wheelchair, Portable
- Device Class
- Class II
- Regulation Number
- 890.3930
- Review Panel
- PM
- Submission Type
A motorized lift device that is not permanently mounted in one location and that is intended for medical purposes to provide a means to move a person with impaired mobility, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).