510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061365Substantially Equivalent

Checkpoint with Accustim Technology

Ndi Medical, LLC, Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061365 is the FDA 510(k) clearance record for CHECKPOINT WITH ACCUSTIM TECHNOLOGY, a class II device, cleared for Ndi Medical, LLC on under FDA product code ETN (Stimulator, Nerve). FDA records list 3 510(k) clearances for Ndi Medical, LLC, from to . As of , FDA records show no recalls naming K061365.

Clearance record

Decision date
Received
(57 days to decision)
Product code
ETN Stimulator, Nerve
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Ndi Medical, LLC One Chagrin Highlands 2000, Cleveland OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ETN

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