RegWardenFDA facility compliance records
Facility

Altivera Medical, Inc.

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2009: 1 recalls; 2017: 1 inspections; 2018: 1 inspections; 2022: 1 inspections1’09’10’11’12’13’14’15’161’171’18’19’20’211’22’23’24’25’26
  • Recalls (1)
  • Inspections (3)

Devices registered here (1)

  • Stimulator, Nerve, Transcutaneous, For Pain Relief
    Product code GZJ (opens in a new tab) · Class II · Neurology · 21 CFR 882.5890

Recalls & enforcement

  • Class IITerminated2009-01-25
    Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.

FDA inspections (3)

  • NAI2022-05-31
    No Action Indicated · Compliance: Devices
  • NAI2018-10-30
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • OAI2017-08-08
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Altivera Medical, Inc. (FEI 3000214920) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000214920-altivera-medical-inc/

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