510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K961809Substantially Equivalent

She-Li TENS Stimulator Model Sl-101 Rx

Medi Consultants, Inc., Paterson NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961809 is the FDA 510(k) clearance record for SHE-LI TENS STIMULATOR MODEL SL-101 RX, a class II device, cleared for Medi Consultants, Inc. on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list one 510(k) clearance for Medi Consultants, Inc. As of , FDA records show no recalls naming K961809.

Clearance record

Decision date
Received
(292 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
Medi Consultants, Inc. 265 Vreeland Ave., Paterson NJ
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