Rich-Mar Winner ST4 Muscle Stimulator, Interferential, and TENS Device
FDA 510(k) K000808 · Rich-Mar Corp.
510(k) numberK000808
Submission
- Device name
- Rich-Mar Winner ST4 Muscle Stimulator, Interferential, and TENS Device
- Applicant
- Rich-Mar Corp.
Inola, OK, US - Received
- March 13, 2000
- Decision date
- August 25, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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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 |
| 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 |
| K950564 | Rich-Mar Us-Ii UltrasoundIMI · Traditional | 05/15/1995SE |
Questions and answers
When was Rich-Mar Winner ST4 Muscle Stimulator, Interferential, and TENS Device cleared by the FDA?
Rich-Mar Winner ST4 Muscle Stimulator, Interferential, and TENS Device (K000808) received a 510(k) decision of Substantially Equivalent on August 25, 2000, 165 days after the submission was received.
What is the product code of K000808?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.