510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K122393Substantially Equivalent

Tg-Body Mi&body S-Trainer

Miga Medical Co., Ltd., Gangnam-Gu, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122393 is the FDA 510(k) clearance record for TG-BODY MI&BODY S-TRAINER, a class II device, cleared for Miga Medical 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 one 510(k) clearance for Miga Medical Co., Ltd. As of , FDA records show no recalls naming K122393.

Clearance record

Decision date
Received
(490 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
Miga Medical Co., Ltd. #821 Samil Plz., 837-26 Yeuksam-Dong, Gangnam-Gu, KR
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