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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: DT-PROBE-A-1; DT-PROBE-A-2; DT-PROBE-V-1; DT-PROBE-V-2; DT-PROBE-V-3; EM-2400; EM-5300; ISTIM EM-5200 (EVERYWAY4ALL) EM-5300; iSTIM PR-02-2; iSTIM PR-02A; iSTIM PR-03; iSTIM PR-03A; iSTIM PR-13A; ISTIM V2 (EVERYWAY4ALL) EM-2400; KWELL EM1 (Intimd); PR-02A (Probe); PR-03A (Probe); PR-04A (Probe); PR-14A (Probe)
Classification Name: STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
Product Code: KPI
Device Class: 2
Regulation Number: 876.5320
Medical Specialty: Gastroenterology
Registered Establishment Name: EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
Registered Establishment Number: 9616877
Premarket Submission Number: K213116
Owner/Operator: EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
Owner/Operator Number: 9043515
Establishment Operations: Manufacturer
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