510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K011429Substantially Equivalent

Model 100 Activity Monitor

Telecom Medical, Inc., Cupertino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011429 is the FDA 510(k) clearance record for MODEL 100 ACTIVITY MONITOR, a class II device, cleared for Telecom Medical, Inc. on under FDA product code GYD (Transducer, Tremor). FDA records list one 510(k) clearance for Telecom Medical, Inc. As of , FDA records show no recalls naming K011429.

Clearance record

Decision date
Received
(65 days to decision)
Product code
GYD Transducer, Tremor
Regulation
21 CFR 882.1950
Device class
Class II
Review panel
Neurology
Applicant
Telecom Medical, Inc. 10900 Lucky Oak Ct., Cupertino CA
510(k) summary
Statement
Third party review
No

Clearances, product code GYD

Trailing 12 months
3 clearances under product code GYD in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GYD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20262
September 20260
October 20260