The following data is part of a premarket notification filed by Pihsiang Machinery Mfg. Co., Ltd. with the FDA for 888 Wnle Powered Wheelchair.
Device ID | K142027 |
510k Number | K142027 |
Device Name: | 888 WNLE POWERED WHEELCHAIR |
Classification | Wheelchair, Powered |
Applicant | PIHSIANG MACHINERY MFG. CO., LTD. 21184 FIGUEROA ST. Carson, CA 90745 |
Contact | David Lin |
Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2014-07-25 |
Decision Date | 2014-10-07 |
Summary: | summary |