Stemplex
FDA 510(k) K781167 · Rich-Mar Corp.
510(k) numberK781167
Submission
- Device name
- Stemplex
- Applicant
- Rich-Mar Corp.
Mchenry, IL, US - Received
- July 13, 1978
- Decision date
- September 15, 1978
- 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 |
|---|---|---|
| K040679 | Rich-Mar Autoprism Infrared LampILY · Traditional | 05/07/2004SE |
| K031018 | Autogel PadMUI · Traditional | 12/08/2003SE |
| K032941 | Autosound 7.6 Muscle Stimulator, TENS, Therapeutic Ultrasound and Combination DeviceIPF · Special | 10/22/2003SE |
| K021483 | Rich-Mar Therasound 6.5 Therapeutic UltrasoundIMI · Traditional | 09/13/2002SE |
| K013771 | Modification to: Winner CM-2 Muscle Stimulator, TENS, Therapeutic Ultrasound and…IPF · Special | 01/18/2002SE |
| K013770 | Modification to: Winner ST-2 StimulatorIPF · Special | 01/18/2002SE |
| K012848 | Winner CM4 Combination UnitGZJ · Traditional | 10/25/2001SE |
| K000808 | Rich-Mar Winner ST4 Muscle Stimulator, Interferential, and TENS DeviceIPF · Traditional | 08/25/2000SE |
| K982544 | Rich-Mar US500, US750, US1000 Therapeutic Unltrasound DevicesIMI · Traditional | 11/19/1998SE |
| K952089 | Rich-Mar Cm-Ii Combined Muscle Stimulator, Interferential, TENS & Therapeutic Ultrasound…LIH · Traditional | 08/11/1995SN |
Questions and answers
When was Stemplex cleared by the FDA?
Stemplex (K781167) received a 510(k) decision of Substantially Equivalent on September 15, 1978, 64 days after the submission was received.
What is the product code of K781167?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.