510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240234Substantially Equivalent

Btl-899Ms

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

K240234 is the FDA 510(k) clearance record for BTL-899MS, a class II device, cleared for BTL Industries, Inc. on under FDA product code IPF (Stimulator, Muscle, Powered). FDA records list 45 510(k) clearances for BTL Industries, Inc., from to . As of , FDA records show no recalls naming K240234.

Clearance record

Decision date
Received
(201 days to decision)
Product code
IPF Stimulator, Muscle, Powered
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
BTL Industries, Inc. 362 Elm St., Marlborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IPF

Trailing 12 months
3 clearances under product code IPF in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IPF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20262
July 20260
August 20260
September 20260
October 20260