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 |