510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893604Substantially Equivalent

TENS Prep

Smith & Nephew United, Inc., Largo FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893604 is the FDA 510(k) clearance record for TENS PREP, a class II device, cleared for Smith & Nephew United, Inc. on under FDA product code GYB (Media, Electroconductive). FDA records list 34 510(k) clearances for Smith & Nephew United, Inc., from to . As of , FDA records show no recalls naming K893604.

Clearance record

Decision date
Received
(189 days to decision)
Product code
GYB Media, Electroconductive
Regulation
21 CFR 882.1275
Device class
Class II
Review panel
Neurology
Applicant
Smith & Nephew United, Inc. 11775 Starkley Rd., Largo FL
Third party review
No

Clearances, product code GYB

Trailing 12 months

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

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