510(k) K193364
K193364 is an FDA 510(k) premarket notification submitted by Plus EV Holdings Dba Intimate Rose for the device "Intimate Rose Kegel Exercise System". The FDA issued a decision of Substantially Equivalent on August 24, 2020. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Plus EV Holdings Dba Intimate Rose has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 2020
- Date Received
- December 4, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Perineometer
- Device Class
- Class II
- Regulation Number
- 884.1425
- Review Panel
- GU
- Submission Type