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
K823906Substantially Equivalent

Telemetry System

Transkinetic Systems, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823906 is the FDA 510(k) clearance record for TELEMETRY SYSTEM, a class II device, cleared for Transkinetic Systems, Inc. on under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency). FDA records list one 510(k) clearance for Transkinetic Systems, Inc. As of , FDA records show no recalls naming K823906.

Clearance record

Decision date
Received
(71 days to decision)
Product code
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Regulation
21 CFR 870.2910
Device class
Class II
Review panel
Cardiovascular
Applicant
Transkinetic Systems, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DRG

Trailing 12 months
2 clearances under product code DRG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260