The following data is part of a premarket notification filed by Merits Health Products Co., Ltd. with the FDA for Merits E600 Series Stair Lift.
Device ID | K073110 |
510k Number | K073110 |
Device Name: | MERITS E600 SERIES STAIR LIFT |
Classification | Transport, Patient, Powered |
Applicant | MERITS HEALTH PRODUCTS CO., LTD. 9, ROAD 36 TAICHUNG INDUSTRIAL PARK Taichung, TW 407 |
Contact | Steve Chao |
Correspondent | Steve Chao MERITS HEALTH PRODUCTS CO., LTD. 9, ROAD 36 TAICHUNG INDUSTRIAL PARK Taichung, TW 407 |
Product Code | ILK |
CFR Regulation Number | 890.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-05 |
Decision Date | 2008-02-06 |
Summary: | summary |