510(k) K850013
- Device
- SYS STIM 206(MODEL-ME 206) MUSCLE STIMULATOR
- Applicant
- METTLER ELECTRONICS CORP.
- 510(k) number
- K850013
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-04-08
- Date received
- 1985-01-02
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROB FLEMING
- Address
- 1333 S. Claudina St. Anaheim CA US 92805 92805
FDA Registration Numbers#
- 8010720
- 3009437400
- 1721293
- 8022189
- 3013927823
- 3011197543
- 2011115
- 3035374386
- 3014315574
- 3013375723
- 3022631685
- 3013401749
- 3004733458
- 3013602304
- 3012651177
- 3017936974
- 3025367760
- 9616086
- 2013558
- 3012316249
- 3010511300
- 3014314933
- 3030956509
- 3027718340
- 9680487
- 3013671142
- 3023339107
- 3012251759
- 3045753434
- 3013917867
- 3007731000
- 3015619973
- 3011564440
- 3005783425
- 3010162782
- 3037609256
- 3007743972
- 3005569927
- 3043012074
- 3005713796
- 8022890
- 1054713
- 3010385841
- 3001431138
- 9613347
- 3007543044
- 3043153468
- 3043011436
- 1061158
- 3004938911
- 3032062344
- 3019055598
- 3005868392
- 3003573572
- 3004264602
- 3019892999
- 3006850006
- 2024292
- 9710582
- 3029312829
- 1055808
- 3008525454
- 3013077196
- 3019705154
- 3011905669
- 2954348
- 3003895865
- 3015452693
- 3010097863
- 3010078417
- 3012981024
- 9611612
- 3010583453
- 3004509773
- 3033847811
- 2026803
- 3013508647
- 9710616
- 3043012240
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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