510(k) K201285
- Device
- InMode Evolve System With The Tone Applicator
- Applicant
- InMode Ltd.
- 510(k) number
- K201285
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-05
- Date received
- 2020-05-13
- 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
- No
Applicant Contact#
- Contact
- Amit Goren
- Address
- Tabor Bldg., Shaar Yokneam Yokneam IL 2069200 2069200
FDA Registration Numbers#
- 3037609256
- 9617486
- 3009411292
- 3038138457
- 9616877
- 3013069546
- 3009494725
- 9615033
- 8040537
- 3030151584
- 3011905669
- 3035374386
- 3011410128
- 3015588280
- 3025235024
- 3005783425
- 3015452693
- 3027241812
- 3005569927
- 3011466827
- 3013077196
- 9710582
- 3022631685
- 3009142693
- 3012168464
- 3005868392
- 1644243
- 3013375723
- 1061158
- 3008048783
- 3044563261
- 3017866822
- 3029312829
- 3008008477
- 1930027
- 3004049909
- 9710567
- 3013508647
- 3009437400
- 3027669735
- 3012316249
- 3004733458
- 3043012074
- 3013401749
- 3005713796
- 3001676837
- 3011564440
- 3015617003
- 3012251759
- 3008273892
- 8022890
- 3010078417
- 3010583453
- 2954348
- 3010097863
- 3007743972
- 3012352782
- 9613462
- 3030956509
- 3005170249
- 2023152
- 3011191255
- 3004438577
- 2013558
- 3027718340
- 3013602304
- 3043012240
- 3014314933
- 2026803
- 3013927823
- 8010720
- 3011267903
- 3005545216
- 2011115
- 3017264244
- 3014774380
- 3019356418
- 3001431138
- 3004413879
Source Documents#
Other 510(k) Records For Product Code IPF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026-06-08 |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati | 2026-06-02 |
| K260142 | StimelMD (SSMD) system | Motion Informatics ltd. | 2026-05-27 |
| K251083 | Compact II | Enraf-Nonius, B.V. | 2025-09-12 |
| K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025-06-04 |
| K241488 | TrainFES Advance | Trainfes | 2025-02-05 |
| K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. , Ltd. | 2024-12-19 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases