510(k) K201958
- Device
- ETD Family of Electrotherapy Devices
- Applicant
- Therasigma, LLC
- 510(k) number
- K201958
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-08-04
- Date received
- 2020-07-14
- 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
- Statement
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Jim Klett
- Address
- 6040 S. Grant St. Suite 100 Washougal WA US 98671 98671
FDA Registration Numbers#
- 3007743972
- 3011562129
- 3010385841
- 3033530347
- 3003740945
- 3042228064
- 3030539046
- 3014314933
- 2024292
- 2013558
- 9710567
- 3016670292
- 3010511300
- 3005170249
- 3008048783
- 9613462
- 1054713
- 3005545216
- 3019055598
- 3017263740
- 3010402752
- 3012651177
- 3025367760
- 1063324
- 3017866822
- 9680487
- 3001676837
- 3005569927
- 3023613474
- 3006153348
- 1055808
- 3013927823
- 3019892999
- 3031233199
- 3003895865
- 3038295706
- 3036471706
- 3004076349
- 3014774380
- 3010078417
- 3006850006
- 3004509773
- 3005868392
- 3023330992
- 3013378804
- 9617486
- 3008273892
- 9613347
- 3030151584
- 1930027
- 3043012074
- 3010280625
- 3003971136
- 3005095860
- 3014315574
- 3012316249
- 3011267903
- 3013401749
- 3008008477
- 3003631667
- 3038138457
- 3012352782
- 3004081884
- 8040537
- 8022189
- 3019356418
- 8022890
- 3010162782
- 3011191255
- 1721293
- 9611612
- 3011905669
- 3019822804
- 3008525454
- 3019705154
- 3010405397
- 3023339107
- 3027241812
- 3013602304
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IPF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K231440 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-11-03 |
| K223027 | NeuroTrigger Basic (NTB) | Neurotrigger | 2023-10-10 |