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510(k) K220454

Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application by Avation Medical, Inc. — Product Code NAM

K220454 is an FDA 510(k) premarket notification submitted by Avation Medical, Inc. for the device "Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application". The FDA issued a decision of Substantially Equivalent on April 3, 2023. 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
April 3, 2023
Date Received
February 17, 2022
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

  • K192731 — ZIDA Wearable Neuromodulation System (March 19, 2021)
  • 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