510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061650Substantially Equivalent

Select TENS, Model 4600S

Empi, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061650 is the FDA 510(k) clearance record for SELECT TENS, MODEL 4600S, a class II device, cleared for Empi on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list 12 510(k) clearances for Empi, from to . As of , FDA records show no recalls naming K061650.

Clearance record

Decision date
Received
(223 days to decision)
Product code
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Empi 599 Cardigan Rd., St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZJ

Trailing 12 months
2 clearances under product code GZJ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260