510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K904796Substantially Equivalent

Medical Alert System, Model 2200 & 4400 V/t

Personal Emergency Response System, East Longmeadow MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904796 is the FDA 510(k) clearance record for MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T, a class II device, cleared for Personal Emergency Response System on under FDA product code ILQ (System, Communication, Powered). FDA records list one 510(k) clearance for Personal Emergency Response System. As of , FDA records show no recalls naming K904796.

Clearance record

Decision date
Received
(34 days to decision)
Product code
ILQ System, Communication, Powered
Regulation
21 CFR 890.3710
Device class
Class II
Review panel
Physical Medicine
Applicant
Personal Emergency Response System 119 Industrial Dr., East Longmeadow MA
Third party review
No

Clearances, product code ILQ

Trailing 12 months

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

FDA records show no clearances under product code ILQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ILQ, 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