510(k) K181955
- Device
- WiEMSpro
- Applicant
- Medical Cables, S.L.
- 510(k) number
- K181955
- Product code
- NGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-02-12
- Date received
- 2018-07-23
- 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
- Jose Fuertes Pena
- Address
- Duque De La Victoria 6, 1 Malaga ES 29015 29015
FDA Registration Numbers#
- 3010852191
- 8040537
- 3011564440
- 9616086
- 3016856381
- 3023205383
- 3012446970
- 3015588280
- 3018608545
- 3010402752
- 3011562129
- 2249769
- 9611558
- 3013602304
- 3001431138
- 3015007456
- 3030970133
- 3009102830
- 3026164517
- 1930027
- 3012500350
- 3043047259
- 3004940677
- 3015214304
- 1061158
- 3025104654
- 3029924973
- 3029939996
- 3015781781
- 3025235024
- 3023808190
- 3011077581
- 3031464228
- 3007689716
- 3006850006
- 3012840029
- 3011466827
- 3007120647
- 3028172072
- 3008048783
- 3008929787
- 3012316249
- 3038295706
- 3016452327
- 2939821
- 3038195193
- 3010880718
- 3027645761
- 3030531253
- 3004049909
- 3021315370
- 3001676837
- 3027605507
- 3035374386
- 3009437400
- 3019822804
- 1528161
- 3004146401
- 3026322014
- 2023152
- 3003740945
- 3013889849
- 3026400760
- 3019356418
- 3015529344
- 8022077
- 3010427504
- 3010097863
- 3013671142
- 3031233197
- 3003678958
- 3012386142
- 3007008050
- 3007615436
- 3018940143
- 3010417025
- 3043013796
- 3014774380
- 3010405397
Source Documents#
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#
summary