The following data is part of a premarket notification filed by Andante Medical Device, Ltd. with the FDA for Smartstep System.
| Device ID | K023161 |
| 510k Number | K023161 |
| Device Name: | SMARTSTEP SYSTEM |
| Classification | Device, Warning, Overload, External Limb, Powered |
| Applicant | ANDANTE MEDICAL DEVICE, LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Contact | Orly Maor |
| Correspondent | Orly Maor ANDANTE MEDICAL DEVICE, LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Product Code | IRN |
| CFR Regulation Number | 890.5575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-23 |
| Decision Date | 2002-12-10 |
| Summary: | summary |