510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K031546Substantially Equivalent

Rainbow Gt-4A Pain Relief Machine

Sino-Us Information, Inc., Woodhaven NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031546 is the FDA 510(k) clearance record for RAINBOW GT-4A PAIN RELIEF MACHINE, a class II device, cleared for Sino-Us Information, Inc. on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list one 510(k) clearance for Sino-Us Information, Inc. As of , FDA records show no recalls naming K031546.

Clearance record

Decision date
Received
(181 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
Sino-Us Information, Inc. 85-13 88th Ave., Woodhaven NY
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