The following data is part of a premarket notification filed by Elidah, Inc. with the FDA for Elitone Device.
| Device ID | K183585 |
| 510k Number | K183585 |
| Device Name: | Elitone Device |
| Classification | Cutaneous Electrode Stimulator For Urinary Incontinence |
| Applicant | Elidah, Inc. 810 Main St., Ste C Monroe, CT 06468 |
| Contact | Gloria Kolb |
| Correspondent | Gloria Kolb Elidah, Inc. 810 Main St., Ste C Monroe, CT 06468 |
| Product Code | QAJ |
| CFR Regulation Number | 876.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851096008018 | K183585 | 000 |
| 00851096008001 | K183585 | 000 |
| 00851096008025 | K183585 | 000 |