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TensCare

TENSCARE LIMITED · Model Ova3 · UDI-DI 05033435138920

NUH
1
510(k) clearances
118
Adverse events
0
Recalls
169
Facilities

Description

The Ova3 is a non-invasive small and convenient unit that can be worn under clothing to provide safe, continuous, drug-free period pain relief whilst maintaining a normal, active lifestyle. The device is battery powered, single channel home using Transcutaneous Electrical Nerve Stimulation (TENS). The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via these self-adhesive electrodes to superficial nerves. The unit is intended for home use by the patient and is designed with simplicity and ease of use in mind. It has four preset treatment Modes. The level of electrical stimulation of Ova3 is easily controlled by the end user using manual, push-button controls. The new device Ova3 uses the same technical principle and substantially equivalent stimulation parameters to predicate devices marketed Livia (K183110) and/or Perfect EMS (K200694) The Ova3 uses a rechargeable Li-Ion polymer battery and a custom TENS. The Ova3 is supplied with adhesive electrode gel pads.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.