510(k) K171978
- Device
- Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
- Applicant
- Shenzhen Dongdixin Technology Co., Ltd.
- 510(k) number
- K171978
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-10-02
- Date received
- 2017-06-30
- 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
- Siping Yuan
- Address
- # 3 Bldg., Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen CN 518108 518108
FDA Registration Numbers#
- 3005868392
- 8040537
- 3011564440
- 9616086
- 2024292
- 3015588280
- 3010402752
- 3011562129
- 3013602304
- 3001431138
- 3013927823
- 9680487
- 1930027
- 3014315574
- 3004733458
- 1061158
- 3043012074
- 3019705154
- 3003631667
- 3003573572
- 3025235024
- 3013069546
- 3011410128
- 3006850006
- 3004938911
- 9611612
- 3013378804
- 3011466827
- 9710582
- 2026803
- 3008048783
- 3012316249
- 3005783425
- 3038295706
- 3036471706
- 3004049909
- 3027669735
- 3001676837
- 3035374386
- 3009437400
- 3019822804
- 1528161
- 3004509773
- 3004146401
- 2023152
- 3003740945
- 1417592
- 3005545216
- 1054713
- 3007743972
- 3019356418
- 3008525454
- 3015529344
- 3016508547
- 1528764
- 3010097863
- 3013671142
- 3013375723
- 3010805941
- 3012386142
- 3010162782
- 3004438577
- 3008008477
- 3011267903
- 3019892999
- 3017936974
- 3014774380
- 3010405397
- 3043657394
- 3011782009
- 9710567
- 3013445676
- 3009494725
- 3033847811
- 9617486
- 3011767724
- 3003971136
- 3009142693
- 3005569927
Source Documents#
Other 510(k) Records For Product Code IPF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K231440 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | 2023-11-03 |
Legacy Summary#
summary
FDA Review#
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