510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944543Substantially Equivalent

Bioflex Garments, Assorted Models

Bioflex, Inc., Columbus OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944543 is the FDA 510(k) clearance record for BIOFLEX GARMENTS, ASSORTED MODELS, a class II device, cleared for Bioflex, Inc. on under FDA product code GXY (Electrode, Cutaneous). FDA records list one 510(k) clearance for Bioflex, Inc. As of , FDA records show 4 recalls naming K944543.

Clearance record

Decision date
Received
(307 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Bioflex, Inc. 736 Kenwick Rd., Columbus OH
510(k) summary
Summary
Third party review
No

Clearances, product code GXY

Trailing 12 months
11 clearances under product code GXY in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code GXY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20262
May 20263
June 20262
July 20261
August 20261
September 20260
October 20260