510(k) K250038
- Device
- Muscle Stimulator Device (PZ-100)
- Applicant
- Zhengzhou PZ Laser Slim Technology Co., Ltd.
- 510(k) number
- K250038
- Product code
- NGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-19
- Date received
- 2025-01-08
- 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
- N
Related Records
Applicant Contact
- Contact
- Hongwei Zhou
- Address
- Rm. 201, 2nd Floor, Bldg. 2, # 52 Hongsong Rd. High-Tech Development Zone Zhengzhou City CN 450001 450001
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
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 | MotiveĀ 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 |
| 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 |