Sys*Stim 240
FDA 510(k) K113017 · Mettler Electronics Corp.
510(k) numberK113017
Submission
- Device name
- Sys*Stim 240
- Applicant
- Mettler Electronics Corp.
Anaheim, CA, US - Received
- October 11, 2011
- Decision date
- June 26, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K233926 | accufitIPF · Traditional | 03/21/2024SE |
| K223802 | accufitIPF · Traditional | 10/06/2023SE |
| K111482 | Sonicator Plus 920IMG · Special | 08/25/2011SE |
| K091540 | MTD 4000ITH · Abbreviated | 10/08/2009SE |
| K071137 | Sonicator Plus 940, Model ME940IMG · Abbreviated | 08/01/2007SE |
| K053546 | Sonicator 740, Model Me 740IMI · Abbreviated | 05/04/2006SE |
| K043586 | Laser Sys*Stim 540, Model Me 540ILY · Abbreviated | 05/06/2005SE |
| K042554 | Auto Therm 390, Model Me 390IMJ · Abbreviated | 10/08/2004SE |
| K031017 | Sys*Stim 208 and 208AIPF · Traditional | 05/30/2003SE |
| K023083 | Silberg T.P.S., Tissue Preparation System, Model Me 800FRN · Abbreviated | 02/28/2003ST |
Questions and answers
When was Sys*Stim 240 cleared by the FDA?
Sys*Stim 240 (K113017) received a 510(k) decision of Substantially Equivalent on June 26, 2012, 259 days after the submission was received.
What is the product code of K113017?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.