Therapeutic Stimulator 2100 (TS-2100)
FDA 510(k) K914904 · Myo/Kinetic Systems, Inc.
510(k) numberK914904
Submission
- Device name
- Therapeutic Stimulator 2100 (TS-2100)
- Applicant
- Myo/Kinetic Systems, Inc.
Menomonee Falls, WI, US - Received
- November 1, 1991
- Decision date
- April 28, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
Other 510(k)s with product code IPF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M)IPF · Traditional | Weero Co., Ltd. | 06/08/2026SE |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
| K260142 | StimelMD (SSMD) systemIPF · Special | Motion Informatics ltd. | 05/27/2026SE |
| K251083 | Compact IIIPF · Traditional | Enraf-Nonius, B.V. | 09/12/2025SE |
| K241433 | EVE Synergy (EVE-20M)IPF · Traditional | Weero Co., Ltd. | 06/04/2025SE |
| K241488 | TrainFES AdvanceIPF · Traditional | Trainfes | 02/05/2025SE |
| K240348 | Quantum Mitohormesis (QMT) (M2101)IPF · Abbreviated | Quantumtx Pte. , Ltd. | 12/19/2024SE |
| K240992 | eMVFit (MVF-10M)IPF · Traditional | Weero Co., Ltd. | 10/10/2024SE |
| K240234 | BTL-899MSIPF · Traditional | BTL Industries, Inc. | 08/17/2024SE |
| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | Sunmed, LLC | 08/02/2024SE |
More from Sunmed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K945937 | TE-800 Pelvic Floor ExerciserHIR · Traditional | 07/14/1995SE |
| K945292 | TS-700P Control XP Electrical StimulatorKPI · Traditional | 04/12/1995SE |
| K944972 | Uro-Gram Cystomrtrogram with UroflowmetryEXY · Traditional | 03/08/1995SE |
| K936041 | Urogram CystometrogramFEN · Traditional | 04/18/1994SE |
| K932611 | Neuromuscular StimulatorGZJ · Traditional | 01/31/1994SE |
| K932764 | Therapeutic Stimulator 300(TS-300) & 300P(TS-300P)IPF · Traditional | 10/01/1993SE |
| K932399 | Therapeutic Stim 200 (TS-200)/200P (TS-200P)IPF · Traditional | 08/11/1993SE |
Questions and answers
When was Therapeutic Stimulator 2100 (TS-2100) cleared by the FDA?
Therapeutic Stimulator 2100 (TS-2100) (K914904) received a 510(k) decision of Substantially Equivalent on April 28, 1992, 179 days after the submission was received.
What is the product code of K914904?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.