Rich-Mar Cm-Ii Combined Muscle Stimulator, Interferential, TENS & Therapeutic Ultrasound Device
FDA 510(k) K952089 · Rich-Mar Corp.
510(k) numberK952089
Submission
- Device name
- Rich-Mar Cm-Ii Combined Muscle Stimulator, Interferential, TENS & Therapeutic Ultrasound Device
- Applicant
- Rich-Mar Corp.
Inola, OK, US - Received
- May 3, 1995
- Decision date
- August 11, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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| K040679 | Rich-Mar Autoprism Infrared LampILY · Traditional | 05/07/2004SE |
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| 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 |
| K950564 | Rich-Mar Us-Ii UltrasoundIMI · Traditional | 05/15/1995SE |
Questions and answers
When was Rich-Mar Cm-Ii Combined Muscle Stimulator, Interferential, TENS & Therapeutic Ultrasound Device cleared by the FDA?
Rich-Mar Cm-Ii Combined Muscle Stimulator, Interferential, TENS & Therapeutic Ultrasound Device (K952089) received a 510(k) decision of Substantially Equivalent for Some Indications on August 11, 1995, 100 days after the submission was received.
What is the product code of K952089?
The FDA product code is LIH – Interferential Current Therapy, a Class II (moderate risk) device regulated under 21 CFR 882.5890.