The following data is part of a premarket notification filed by Andante Medical Devices Ltd. with the FDA for Smartstep System/smarstep Clinic System.
Device ID | K060150 |
510k Number | K060150 |
Device Name: | SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM |
Classification | Device, Warning, Overload, External Limb, Powered |
Applicant | ANDANTE MEDICAL DEVICES LTD. 7 JABOTINSKY STREET (MOSHE AVIV TOWER) Ramat Gan, IL 52520 |
Contact | Dorit Winitz |
Correspondent | Dorit Winitz ANDANTE MEDICAL DEVICES LTD. 7 JABOTINSKY STREET (MOSHE AVIV TOWER) Ramat Gan, IL 52520 |
Product Code | IRN |
CFR Regulation Number | 890.5575 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-20 |
Decision Date | 2006-02-23 |
Summary: | summary |