510(k) K211942
- Device
- Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
- Applicant
- Shenzhen Osto Technology Company Limited
- 510(k) number
- K211942
- Product code
- NGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-13
- Date received
- 2021-06-23
- 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
- Li Yang
- Address
- #43 Longfeng Rd., Xinsheng Community Longgang St. Longgang District Shenzhen CN 518116 518116
FDA Registration Numbers#
- 3013889849
- 3019356418
- 3037609256
- 3017264244
- 3033844600
- 3015619973
- 3026400760
- 3011197543
- 3010770433
- 3033850524
- 3008915316
- 3008048783
- 3027718340
- 3030412027
- 3007120647
- 3016832824
- 3009494725
- 3023339107
- 3038195193
- 3016452327
- 3033273466
- 3017132875
- 3033881629
- 3010417025
- 3026322014
- 8022077
- 3009102830
- 1063974
- 3007615436
- 3023205383
- 3043149902
- 3031233197
- 3011721071
- 3035374386
- 3006807694
- 3044175602
- 3038620598
- 3042953831
- 3004146401
- 3042190125
- 2011068
- 3021635975
- 3013602304
- 3026753375
- 3032062344
- 3007543044
- 3001676837
- 3025235024
- 3045753434
- 3043047259
- 3008770252
- 3013957847
- 3007731000
- 3007689716
- 3003446042
- 2013558
- 3010485091
- 3043013796
- 3008929787
- 3012386142
- 3015214304
- 3005238200
- 3006551156
- 3042971880
- 3003678958
- 3003740945
- 3003895865
- 3004081884
- 3016670292
- 3004264602
- 3026164517
- 3030539046
- 3028172072
- 3006850006
- 3008806536
- 3033530347
- 1930027
- 3009488655
- 3011564440
Source Documents#
Other 510(k) Records For Product Code NGX#
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| 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 |