510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K163694Substantially Equivalent

Rooti Rx ECG Event Recorder, Rooti Link APP Software

Rooti Labs, Ltd., Taipei, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163694 is the FDA 510(k) clearance record for Rooti Rx ECG Event Recorder, Rooti Link APP Software, a class II device, cleared for Rooti Labs , Ltd. on under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency). FDA records list one 510(k) clearance for Rooti Labs , Ltd. As of , FDA records show no recalls naming K163694.

Clearance record

Decision date
Received
(314 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
Rooti Labs , Ltd. 5f-1, #17, Zhouzi St., Neihu Dist., Taipei, TW
510(k) summary
Summary PDF
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