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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Omnistim FX2; Omnistim FX2 Pro; Omnistim FX2 Pro Sport; Omnistim Sport Elite
Classification Name: STIMULATOR, MUSCLE, POWERED
Product Code: IPF
Device Class: 2
Regulation Number: 890.5850
Medical Specialty: Physical Medicine
Registered Establishment Name: ZMI ELECTRONICS LTD.
Registered Establishment Number: 9617486
Premarket Submission Number: K945509
Owner/Operator: ZMI ELECTRONICS, LTD.
Owner/Operator Number: 9035676
Establishment Operations: Contract Manufacturer; Manufacturer
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