510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091833Substantially Equivalent

Gem-Stone Abdominal Training System; Model Gem-Tone 310Pe/320pe/330pe/340pe/350pe.

Gemore Technology Co., Ltd., Tan Shui, New Taipei City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091833 is the FDA 510(k) clearance record for GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE., a class II device, cleared for Gemore Technology Co, Ltd. on under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning). FDA's definition for product code NGX reads: "A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties...". FDA records list 14 510(k) clearances for Gemore Technology Co, Ltd., from to . As of , FDA records show no recalls naming K091833.

Clearance record

Decision date
Received
(116 days to decision)
Product code
NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Applicant
Gemore Technology Co, Ltd. 11 Floor , #29-5, Sec.2, Chung Cheng E. Rd.,, Tan Shui, New Taipei City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NGX

Trailing 12 months
6 clearances under product code NGX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NGX, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260