510(k) K122393
- Device
- TG-BODY MI&BODY S-TRAINER
- Applicant
- Miga Medical Co., Ltd.
- 510(k) number
- K122393
- Product code
- NGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-12-10
- Date received
- 2012-08-07
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered, For Muscle Conditioning
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- YANG HO DONG
- Address
- #821 Samil Plz., 837-26 Yeuksam-Dong Gangnam-Gu KR 135-768 135-768
FDA Registration Numbers#
- 3011792111
- 3044675848
- 3011562129
- 3010385841
- 3033530347
- 3003740945
- 3042953831
- 3030539046
- 3014314933
- 3017887928
- 3008507279
- 2013558
- 3014388884
- 3003446042
- 3016670292
- 3016674228
- 3026322014
- 3005170249
- 3007689716
- 3016452327
- 3008048783
- 9613462
- 3030970133
- 3030531253
- 3010402752
- 3012651177
- 3025367760
- 3030597665
- 3011077581
- 3001676837
- 3027645761
- 2954354
- 3017953405
- 3003678958
- 3005569927
- 3023613474
- 3015282440
- 3014647250
- 3038195193
- 3007120647
- 3006153348
- 3027062656
- 3003895865
- 1063974
- 3038295706
- 3011120089
- 3014774380
- 3010078417
- 3016856381
- 3006850006
- 3016832824
- 3023330992
- 3026400760
- 3025428426
- 3031233197
- 9617486
- 3013613043
- 3004541594
- 9613347
- 3033881629
- 1930027
- 3012729332
- 3043149902
- 3018608545
- 3009102830
- 3008806536
- 3012316249
- 3012725363
- 3042190125
- 3028172072
- 3008929787
- 3038138457
- 3004081884
- 3010852191
- 8040537
- 3019356418
- 9611558
- 3007008050
- 3011191255
Source Documents#
Other 510(k) Records For Product Code NGX#
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|---|---|---|---|
| K253926 | Diacore | ShenB Co., Ltd. | 2026-04-10 |
| K253636 | Zionic Pro Max (EMS) | Termosalud S.L. | 2026-03-12 |
| K253408 | CoolTone | Zimmer Medizinsysteme GmbH | 2026-01-16 |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) | Guangzhou Longest Medical Technology Co., Ltd. | 2025-12-09 |
| K253478 | Motive™ Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. | 2025-11-06 |
| K251594 | truFlex | Syrma Johari Medtech Limited | 2025-08-28 |
| K251706 | TENS and EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-07-30 |
| K251378 | CoolTone | Zimmer Medizinsysteme GmbH | 2025-07-14 |
| K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025-07-02 |
| K250759 | 3 in 1 TENS UNIT | Changsha Anxiang Medical Technology Co., Ltd. | 2025-06-13 |
| K242926 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | 2025-05-30 |
| K250038 | Muscle Stimulator Device (PZ-100) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-05-19 |
| K243165 | Limfa Therapy System (Limfa Therapy) | Eywa Srl | 2025-05-15 |
| K250146 | SofWave System | Sofwave Medical, Ltd. | 2025-04-18 |
| K243763 | Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. | 2025-03-12 |