510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040054Substantially Equivalent

Back in Action Compression & Support with Magnets for the Lower Back, Knee and Ankle

Theodore Barash, Delray Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040054 is the FDA 510(k) clearance record for BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE, a class I device, cleared for Theodore Barash on under FDA product code FQM (Bandage, Elastic). FDA records list one 510(k) clearance for Theodore Barash. As of , FDA records show no recalls naming K040054.

Clearance record

Decision date
Received
(106 days to decision)
Product code
FQM Bandage, Elastic
Regulation
21 CFR 880.5075
Device class
Class I
Review panel
General Hospital
Applicant
Theodore Barash 16879 C Isle Of Palms Dr., Delray Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FQM

Trailing 12 months

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

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