510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250309Substantially Equivalent

Btl-199

BTL Industries, Inc, Marlborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250309 is the FDA 510(k) clearance record for BTL-199, a class II device, cleared for BTL Industries, Inc. on under FDA product code QPL (Electromagnetic Stimulator, Pain Relief). FDA's definition for product code QPL reads: "Intended to apply a magnetic-field induced electrical current to treat pain". FDA records list 45 510(k) clearances for BTL Industries, Inc., from to . As of , FDA records show no recalls naming K250309.

Clearance record

Decision date
Received
(185 days to decision)
Product code
QPL Electromagnetic Stimulator, Pain Relief
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
BTL Industries, Inc. 362 Elm St., Marlborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QPL

Trailing 12 months

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

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