510(k) K223027
- Device
- NeuroTrigger Basic (NTB)
- Applicant
- Neurotrigger
- 510(k) number
- K223027
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-10
- Date received
- 2022-09-29
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered
- 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
- Nikolai Kuincher
- Address
- Nirim 3 Tel Aviv IL 67060 67060
FDA Registration Numbers
- 3003895865
- 3014774380
- 3004081884
- 3004146401
- 3010402752
- 3004264602
- 1528161
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- 3015452693
Source Documents
Other 510(k) Records For Product Code IPF
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| K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024-10-10 |
| K240234 | BTL-899MS | BTL Industries, Inc. | 2024-08-17 |
| K233098 | MYOTouch Muscle Stimulator | Sunmed, LLC | 2024-08-02 |
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | Edan Instruments, Inc. | 2024-05-16 |
| K233926 | accufit | Mettler Electronics Corporation | 2024-03-21 |
| K233485 | M-Wave | Zynex Medical, Inc. | 2024-01-26 |
| K232937 | BTL-899M | BTL Industries, Inc. | 2023-12-26 |
| K230701 | Stim2Go | PAJUNK GmbH Medizintechnologie | 2023-11-24 |
| K231440 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-11-03 |
| K223802 | accufit | Mettler Electronics Corporation | 2023-10-06 |
| K221274 | StarFormer, TightWave | Fotona D.O.O. | 2023-09-29 |