510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991397Substantially Equivalent

Transcutaneous Electrical Nerve Stimulator Se-30 TENS

Sein Electronics Co., Ltd., Buffalo Grove IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991397 is the FDA 510(k) clearance record for TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS, a class II device, cleared for Sein Electronics Co., Ltd. on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list 12 510(k) clearances for Sein Electronics Co., Ltd., from to . As of , FDA records show no recalls naming K991397.

Clearance record

Decision date
Received
(296 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
Sein Electronics Co., Ltd. 1540 Barclay Blvd., Buffalo Grove IL
510(k) summary
Summary
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