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Aleve

BAYER HEALTHCARE LLC · Model 1613538 · UDI-DI 00325866565044

NUH
10
510(k) clearances
118
Adverse events
0
Recalls
169
Facilities

Description

Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, physical therapists, and chiropractor's offices. Aleve Direct Therapy TENS Device is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The kit contains a device, 1 pair of gel pads, 2-AAA batteries, 1 Phillips head screwdriver and a wireless remote control.

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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.