510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101109Substantially Equivalent

Vivatrak

Wireless Medcare, LLC, Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101109 is the FDA 510(k) clearance record for VIVATRAK, a class I device, cleared for Wireless Medcare, LLC on under FDA product code KMI (Monitor, Bed Patient). FDA records list one 510(k) clearance for Wireless Medcare, LLC. As of , FDA records show no recalls naming K101109.

Clearance record

Decision date
Received
(86 days to decision)
Product code
KMI Monitor, Bed Patient
Regulation
21 CFR 880.2400
Device class
Class I
Review panel
General Hospital
Applicant
Wireless Medcare, LLC 1733 Canton Ln., Marietta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KMI

Trailing 12 months

FDA records hold no clearances under product code KMI in the trailing twelve months.

FDA records show no clearances under product code KMI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260