510(k) K202638
- Device
- Pain Therapy Device
- Applicant
- Guangzhou Xinbo Electronic Co., Ltd.
- 510(k) number
- K202638
- Product code
- NGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-07-15
- Date received
- 2020-09-11
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sammy Li
- Address
- #23 Bldg., The Second Phase, Huachuang Animation Industry Park, Panyu Guangzhou CN 511450 511450
FDA Registration Numbers#
- 3037609256
- 3008753275
- 9617486
- 3038138457
- 3016830208
- 9616877
- 3010770433
- 3012725363
- 3009494725
- 3025104654
- 8040537
- 3020769982
- 3033273466
- 3023808190
- 3035374386
- 3015282440
- 3015588280
- 3025235024
- 3029939996
- 3008729899
- 3005569927
- 3011466827
- 3015007456
- 3025428426
- 3017887847
- 3014647250
- 3013503862
- 3030412027
- 3031464228
- 3028172072
- 3031233197
- 3030597665
- 3015889734
- 2954354
- 3013889849
- 1061158
- 3008048783
- 3044563261
- 3004940677
- 3029312829
- 3003678958
- 1930027
- 3004049909
- 2011068
- 3009437400
- 3012316249
- 3016452327
- 3018940143
- 3011120089
- 3001676837
- 3011564440
- 3004541594
- 3010880718
- 3042190125
- 3010078417
- 3016170453
- 3011792111
- 3026400760
- 3012500350
- 3010097863
- 3008915316
- 9613462
- 3044675848
- 3010427504
- 3024182169
- 3015414274
- 3010852191
- 3005170249
- 2023152
- 3027605507
- 3026322014
- 3011191255
- 3012176966
- 3017887928
- 2013558
- 3011077581
- 3007120647
- 3017173524
- 3013602304
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NGX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases