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510(k) K101109

VIVATRAK by Wireless Medcare, LLC — Product Code KMI

K101109 is an FDA 510(k) premarket notification submitted by Wireless Medcare, LLC for the device "VIVATRAK". The FDA issued a decision of Substantially Equivalent on July 15, 2010. The device falls under product code KMI (Monitor, Bed Patient), a Class I device regulated under 21 CFR 880.2400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2010
Date Received
April 20, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Bed Patient
Device Class
Class I
Regulation Number
880.2400
Review Panel
HO
Submission Type

Other clearances for product code KMI

  • K141877 — LEAF PATIENT MONITORING SYSTEM (November 10, 2014)
  • K131585 — INTEL-GE CARE INNOVATIONS QUIETCARE (October 8, 2013)
  • K130752 — DYNASENSE SYSTEM (August 15, 2013)
  • K090138 — MOBILECARE MONITOR, MODEL 2100 (April 24, 2009)
  • K942770 — ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR (December 23, 1994)
  • K943481 — INFORMER PLUS (November 2, 1994)
  • K933552 — PM-PAGER (September 22, 1994)
  • K934344 — HOME AMB-ALERT (April 29, 1994)
  • K940405 — TELETOM (April 14, 1994)
  • K924433 — SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1 (June 24, 1993)

FDA data resources