510(k) K134001
- Device
- FIREFLY
- Applicant
- FIRSTKIND LIMITED
- 510(k) number
- K134001
- Product code
- NGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-05-15
- Date received
- 2013-12-27
- 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
- SHEILA HEMEON-HEYER
- Address
- 231 Fairbanks St. West Boylston MA US 01583 01583
FDA Registration Numbers#
- 3015007456
- 3015214304
- 3033844600
- 3010880718
- 3004081884
- 3026322014
- 3010097863
- 3016832824
- 3009102830
- 3023613474
- 3005170249
- 3008345424
- 3012840029
- 3008806536
- 3025367760
- 3012651177
- 3030412027
- 1061158
- 3013423303
- 3015452693
- 3017887847
- 3038295706
- 3007615436
- 3012729332
- 3006850006
- 3004183512
- 3015282440
- 3010078417
- 3025235024
- 3014647250
- 1054713
- 3026400760
- 3035374386
- 9611558
- 3012134907
- 3009437400
- 3015529344
- 3010385841
- 3010427504
- 3007120647
- 3018940143
- 3001676837
- 9616086
- 3043657394
- 3043149902
- 3024182169
- 3011767724
- 3016452327
- 3005569927
- 3030597665
- 3021315370
- 3016856381
- 3042190125
- 3012176966
- 3006551156
- 3044175602
- 3004049909
- 1832894
- 3016830208
- 2011068
- 3033850524
- 3011792111
- 3038620598
- 3006153348
- 2249769
- 3016170453
- 3009488655
- 3008929787
- 3010632563
- 3042268484
- 3048246437
- 3031464228
- 3004146401
- 3003740945
- 9617486
- 3038311114
- 3011197543
- 3018109879
- 3017450375
Source Documents#
Other 510(k) Records For Product Code NGX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Beijing Winkonlaser Technology Limited | 2026-08-13 |
| 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 |
Legacy Summary#
summary
FDA Review#
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