510(k) K250759
- Device
- 3 in 1 TENS UNIT
- Applicant
- Changsha Anxiang Medical Technology Co., Ltd.
- 510(k) number
- K250759
- Product code
- NGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-13
- Date received
- 2025-03-13
- 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
- N
Related Records
Applicant Contact
- Contact
- William Fu
- Address
- Rm. 2404, Kairui Bldg.,# 245 Laodong W. Rd., Tianxin District Changsha CN 410007 410007
FDA Registration Numbers
- 3033850524
- 3020769982
- 3012446970
- 3014388884
- 2249769
- 3027718340
- 1832894
- 3015619973
- 8022077
- 2011068
- 3033530347
- 3035374386
- 3025379728
- 3028172072
- 3011792111
- 3007615436
- 3012729332
- 9616877
- 3032062344
- 3010852191
- 3038295706
- 3026753375
- 3015214304
- 3016674228
- 2954354
- 3025104654
- 3006515340
- 3031233197
- 3008915316
- 3038138457
- 3009494725
- 3017173524
- 3042190125
- 3008048783
- 3044175602
- 3003678958
- 3015588280
- 3013957847
- 3017887928
- 3038311114
- 3006850006
- 3011197543
- 3013613043
- 3013503862
- 3043047259
- 3013671142
- 3004081884
- 3033273466
- 3016832824
- 3018608545
- 3015007456
- 3022929665
- 3014314933
- 3007731000
- 3027503912
- 9616086
- 3015414274
- 3026322014
- 3005621440
- 9613347
- 3010078417
- 3025235024
- 3042971880
- 3009102830
- 3015889734
- 3007502541
- 1061158
- 3004940677
- 3004264602
- 3007689716
- 3010770433
- 3015282440
- 3023330992
- 3012386142
- 3026164517
- 3008929787
- 3024182169
- 3011050674
- 3016670292
- 3027645761
Source Documents
510(k) summary PDF not indicated by FDA
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| 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 |
| K241601 | EMS (FlexPulse, MagnaCore, Magnetika) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | 2025-02-25 |