Rich-Mar Carbon Electrodes
FDA 510(k) K950491 · Rich-Mar Corp.
510(k) numberK950491
Submission
- Device name
- Rich-Mar Carbon Electrodes
- Applicant
- Rich-Mar Corp.
Inola, OK, US - Received
- February 6, 1995
- Decision date
- March 29, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K021483 | Rich-Mar Therasound 6.5 Therapeutic UltrasoundIMI · Traditional | 09/13/2002SE |
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| 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 |
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Questions and answers
When was Rich-Mar Carbon Electrodes cleared by the FDA?
Rich-Mar Carbon Electrodes (K950491) received a 510(k) decision of Substantially Equivalent on March 29, 1995, 51 days after the submission was received.
What is the product code of K950491?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.