FDA Device Intelligence
HomeTENSCARE LIMITED › TensCare

TensCare

TENSCARE LIMITED · Model Unifit · UDI-DI 05033435136209

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

Description

Unifit combines the treatment capabilities of a TENS device, an EMS or NMES device, and a relaxing massage stimulator in one unit. It sends a small and gentle stimulation (similar to your natural nerve impulses) to the muscles being treated via two or four auto-adhesive electrode pads, in order to help you to firm and tone your body. Unifit is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Unifit is intended for over-the-counter use. The device is battery powered, two channels home use neuromuscular stimulation. 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 self-adhesive electrodes to nerves and muscles. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has preset treatment programs and manually adjustable programmes are available.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.