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FDA 510(k), K163288, Pelvifine Pelvic Muscle Trainer
FDA 510(k), K163288, Pelvifine Pelvic Muscle Trainer
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510(K) Number: K163288
Device Name: Pelvifine Pelvic Muscle Trainer
Manufacturer: Tony Tony
Device Classification Name: Stimulator, Electrical, Non-Implantable, For Incontinence
Regulation Number: KPI
Classification Product Code: KXA
Date Received: 11/22/2016
Decision Date: 01/18/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Pelvifine Pelvic Muscle Trainer
Manufacturer: Tony Tony
Device Classification Name: Stimulator, Electrical, Non-Implantable, For Incontinence
Regulation Number: KPI
Classification Product Code: KXA
Date Received: 11/22/2016
Decision Date: 01/18/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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