Elitone Device
FDA 510(k) clearance K183585 · decided 2019-02-11
Clearance details
- K-number
- K183585
- Device name
- Elitone Device
- Applicant
- Elidah, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-12-21
- Decision date
- 2019-02-11
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- QAJ
- Device class
- 2
- Regulation number
- 876.5330
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Monroe, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Elitone for Men (K253285) | Elidah, Inc. | 2026-01-23 |
| ELITONE Urge Urinary Incontinence Device (K223884) | Elidah, Inc. | 2023-02-24 |
| INNOVO (K192357) | Atlantic Therapeutics, Ltd. | 2020-01-16 |
| Innovo (DEN170049) | Bio-Medical Research, Ltd. | 2018-11-06 |
Recalls involving this device
No recalls on record reference this clearance.