510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K884833Substantially Equivalent

Ultra 2000 (t.e.n.s.)

Maxima Intl., Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884833 is the FDA 510(k) clearance record for ULTRA 2000 (T.E.N.S.), a class II device, cleared for Maxima Intl., Inc. on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list one 510(k) clearance for Maxima Intl., Inc. As of , FDA records show no recalls naming K884833.

Clearance record

Decision date
Received
(87 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
Maxima Intl., Inc. P.O. Box 526944, Miami FL
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