The following data is part of a premarket notification filed by Exodus Innovations with the FDA for Zida Wearable Neuromodulation System.
| Device ID | K192731 |
| 510k Number | K192731 |
| Device Name: | ZIDA Wearable Neuromodulation System |
| Classification | Stimulator, Peripheral Nerve, Non-implanted, For Pelvic Floor Dysfunction |
| Applicant | Exodus Innovations 1 Exodus Road Sufa, IL 85457 |
| Contact | Isaac Oppenheim |
| Correspondent | Cherita James M Squared Associates, Inc 575 8th Ave Suite 1212 New York, NY 10018 |
| Product Code | NAM |
| CFR Regulation Number | 876.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2021-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07297539014711 | K192731 | 000 |
| 07297539082154 | K192731 | 000 |
| 07297539081164 | K192731 | 000 |
| 07297539080174 | K192731 | 000 |
| 07297539071165 | K192731 | 000 |
| 07297539077105 | K192731 | 000 |
| 07297539076115 | K192731 | 000 |
| 07297539075125 | K192731 | 000 |
| 07297539074135 | K192731 | 000 |
| 07297539073145 | K192731 | 000 |
| 07297539072155 | K192731 | 000 |
| 07297539070175 | K192731 | 000 |
| 07297539083144 | K192731 | 000 |
| 07297539084134 | K192731 | 000 |
| 07297539008710 | K192731 | 000 |
| 07297539008611 | K192731 | 000 |
| 07297539008413 | K192731 | 000 |
| 07297539008314 | K192731 | 000 |
| 07297539008215 | K192731 | 000 |
| 07297539008116 | K192731 | 000 |
| 07297539008017 | K192731 | 000 |
| 07297539008512 | K192731 | 000 |
| 07297539087104 | K192731 | 000 |
| 07297539086114 | K192731 | 000 |
| 07297539085124 | K192731 | 000 |
| 07297539014728 | K192731 | 000 |