510(k) DEN170049
DEN170049 is an FDA 510(k) premarket notification submitted by Bio-Medical Research, Ltd. for the device "Innovo". The FDA issued a decision of De Novo Granted on Nov 6, 2018. The device falls under product code QAJ (Cutaneous Electrode Stimulator For Urinary Incontinence), a Class II device regulated under 21 CFR 876.5330. Bio-Medical Research, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Nov 6, 2018
- Date Received
- Sep 18, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cutaneous Electrode Stimulator For Urinary Incontinence
- Device Class
- Class II
- Regulation Number
- 876.5330
- Review Panel
- GU
- Submission Type
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.