510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990323Substantially Equivalent

Te Me Na Polystim Nerve Stimilator

Te ME NA S.A.R.L., Oldsmar FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990323 is the FDA 510(k) clearance record for TE ME NA POLYSTIM NERVE STIMILATOR, a class II device, cleared for Te ME NA S.A.R.L. on under FDA product code BXN (Stimulator, Nerve, Battery-Powered). FDA records list 5 510(k) clearances for Te ME NA S.A.R.L., from to . As of , FDA records show one recall naming K990323.

Clearance record

Decision date
Received
(969 days to decision)
Product code
BXN Stimulator, Nerve, Battery-Powered
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Te ME NA S.A.R.L. 390 Scarlet Blvd., Oldsmar FL
510(k) summary
Statement
Third party review
No

Clearances, product code BXN

Trailing 12 months

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

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