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510(k) Data Aggregation
K Number
K193374Device Name
TumEase Acupressure Bracelets
Manufacturer
MumEase
Date Cleared
2020-03-04
(90 days)
Product Code
MVV
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MumEase
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The acupressure bracelets are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
Device Description
The TumEase Acupressure bracelet is a wrist bracelet that has a small round bump on the inside face of the bracelet. This small bump is manually aligned with the P6 (Neiguan or Pericardium) acupressure point. The bracelet is affixed using a Velcro strap and the desire amount of pressure is applied. One key design feature is the ability to adjust the pressure level using the "tightness" of the Velcro strap. More pressure generally increases the desired anti-nausea affect. The functionality of the Veloro strap allows each patient the ability to find the right amount of pressure for themselves based on their condition and needs. In addition, the TumEase bracelets are designed to be cosmetically attractive. It is supplied to the counter (non-sterile). The acupressure bracelets are intended to be worn over a thin fabric. It can be used as frequently as needed by the patient.
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