510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945803Substantially Equivalent

Thermaflex, Model Sd 55 C.p.m.h.

Burke Neutech, Inc., Largo FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945803 is the FDA 510(k) clearance record for THERMAFLEX, MODEL SD 55 C.P.M.H., a class I device, cleared for Burke Neutech, Inc. on under FDA product code JFA (Exerciser, Finger, Powered). FDA records list 7 510(k) clearances for Burke Neutech, Inc., from to . As of , FDA records show no recalls naming K945803.

Clearance record

Decision date
Received
(164 days to decision)
Product code
JFA Exerciser, Finger, Powered
Regulation
21 CFR 890.5410
Device class
Class I
Review panel
Physical Medicine
Applicant
Burke Neutech, Inc. 11701 S. Belcher Rd.,, Largo FL
510(k) summary
Summary
Third party review
No

Clearances, product code JFA

Trailing 12 months

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

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