The following data is part of a premarket notification filed by Lloyd Linden, Inc. with the FDA for Lloyd Linden, Model E04.
Device ID | K071761 |
510k Number | K071761 |
Device Name: | LLOYD LINDEN, MODEL E04 |
Classification | Wheelchair, Standup |
Applicant | LLOYD LINDEN, INC. ZHUANGJING ROAD Banqiao, Taipei County, TW 220 |
Contact | Junnata Chang |
Correspondent | Junnata Chang LLOYD LINDEN, INC. ZHUANGJING ROAD Banqiao, Taipei County, TW 220 |
Product Code | IPL |
CFR Regulation Number | 890.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-06-29 |
Decision Date | 2007-08-03 |
Summary: | summary |