Multistim Plus
FDA 510(k) K895983 · Excel Tech. , Ltd.
510(k) numberK895983
Submission
- Device name
- Multistim Plus
- Applicant
- Excel Tech. , Ltd.
Oakville,Ontario, CA - Received
- September 25, 1989
- Decision date
- February 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K062549 | Xltek Stimulator Probes, Models 105233, 105234, 105235, 105236, 105237 and 105238ETN · Traditional | 10/04/2006SE |
| K061269 | Xltek Clean Signal Adhesive ElectrodesGXY · Traditional | 08/14/2006SE |
| K053386 | Xltek EMU40 EEG Headbox, Model PK1072GWQ · Traditional | 04/21/2006SE |
| K053058 | Xltek Neuropath, Model PK1070JXE · Traditional | 02/07/2006SE |
| K052112 | Xltek Xcalibur Emg / LT, Model PK1P33, PK1059IKN · Special | 10/28/2005SE |
| K052111 | Xltek Clear Signal Sub-Dermal Needle, Models 102889, 102798, 102799, 102382GXZ · Abbreviated | 08/17/2005SE |
| K042223 | Xltek Connex Ip Headbox, Model 1054OMB · Special | 09/16/2004SE |
| K042150 | Xltek Trex MODEL#10309GWQ · Special | 08/27/2004SE |
| K040358 | Xltek Protektor Stimulator, Models 10247 & 10248GWF · Traditional | 08/06/2004SE |
| K040360 | EMU128S, Model EX-NW-128SGWQ · Special | 03/12/2004SE |
Questions and answers
When was Multistim Plus cleared by the FDA?
Multistim Plus (K895983) received a 510(k) decision of Substantially Equivalent on February 20, 1990, 148 days after the submission was received.
What is the product code of K895983?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.