510(k) K914904
- Device
- THERAPEUTIC STIMULATOR 2100 (TS-2100)
- Applicant
- MYO/KINETIC SYSTEMS, INC.
- 510(k) number
- K914904
- Product code
- IPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-04-28
- Date received
- 1991-11-01
- 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
- HASSAN HAMEDI
- Address
- N84 W13562 Leon Rd. Menomonee Falls WI US 53051 53051
FDA Registration Numbers#
- 3011767724
- 3001431138
- 3011267903
- 3015529344
- 8010720
- 1055808
- 9617486
- 3032062344
- 3014774380
- 3035374386
- 9613462
- 3011562129
- 3004509773
- 8040537
- 3005095860
- 3007731000
- 1061158
- 3012386142
- 3009494725
- 3016512343
- 3017060146
- 3004413879
- 3013375723
- 3012316249
- 3015617003
- 3010280625
- 1063324
- 3013508647
- 9710616
- 3043011436
- 3019892999
- 3027241812
- 1721293
- 3020683829
- 2011115
- 3043657394
- 3010405397
- 8022189
- 3023339107
- 3019705154
- 3030956509
- 3012352782
- 3010078417
- 3005344585
- 1528161
- 3045753434
- 3038295706
- 3007502541
- 3037609256
- 3005868392
- 3015452693
- 9616877
- 3033530347
- 3010583453
- 3019822804
- 3012651177
- 2024292
- 2954348
- 3010402752
- 3011905669
- 3016508547
- 3025367760
- 3009538657
- 3011782009
- 3004938911
- 3022631685
- 8022890
- 3010385841
- 3029312829
- 9680487
- 3011466827
- 3008525454
- 3016670292
- 3019356418
- 3027718340
- 3017264244
- 3004733458
- 9710580
- 3004183512
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#
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
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