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510(k) K192731

ZIDA Wearable Neuromodulation System by Exodus Innovations — Product Code NAM

K192731 is an FDA 510(k) premarket notification submitted by Exodus Innovations for the device "ZIDA Wearable Neuromodulation System". The FDA issued a decision of Substantially Equivalent on March 19, 2021. The device falls under product code NAM (Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence), a Class II device regulated under 21 CFR 876.5310.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2021
Date Received
September 27, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Device Class
Class II
Regulation Number
876.5310
Review Panel
GU
Submission Type

Other clearances for product code NAM

  • K220454 — Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Applicat (April 3, 2023)
  • K132561 — NURO NEUROMODULATION SYSTEM (November 5, 2013)
  • K101847 — URGENT PC STIMULATOR; URGENT PC LEAD SET (October 21, 2010)
  • K071822 — URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 (August 20, 2007)
  • K061333 — URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 (July 3, 2006)
  • K052025 — URGENT PC NEUROMODULATION SYSTEM (October 17, 2005)
  • DEN000002 — UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE (February 9, 2000)

FDA data resources