Autogel Pad
FDA 510(k) K031018 · Rich-Mar Corp.
510(k) numberK031018
Submission
- Device name
- Autogel Pad
- Applicant
- Rich-Mar Corp.
Inola, OK, US - Received
- March 31, 2003
- Decision date
- December 8, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K253255 | Non-Sterile Ultrasound Gel Sterile Ultrasound GelMUI · Traditional | Foshan Pingchuang Medical Technology Co., Ltd. | 06/17/2026SE |
| K252337 | EdgeFlow Gel PadMUI · Traditional | Edgecare, Inc. | 04/24/2026SE |
| K242167 | Sterile and Non-Sterile Ultrasonic Coupling AgentMUI · Traditional | Anhui Deepblue Medical Technology Co., Ltd. | 09/19/2024SE |
| K241789 | Non-Sterile Ultrasound Transmission GelsMUI · Traditional | Hony Medical Co., Ltd. | 07/24/2024SE |
| K232957 | Sterile and Non-Sterile Ultrasound GelsMUI · Traditional | Jianerkang Medical Co., Ltd. | 12/15/2023SE |
| K221999 | Ultrasound Transmission GelsMUI · Traditional | Hony Medical Co., Ltd. | 08/30/2022SE |
| K211691 | Ultrast GelMUI · Traditional | Ultrast, Inc. | 12/22/2021SE |
| K190591 | Safergel Sterile Ultrasound GelMUI · Traditional | Safersonic Us, Inc. | 10/04/2019SE |
| K181363 | EcoVue Sterile and Non-Sterile Ultrasound GelsMUI · Traditional | H R Pharmaceuticals, Inc. | 06/13/2018SE |
| K163027 | Ultra/Phonic Free Conductivity GelMUI · Traditional | Pharmaceutical Innovations, Inc. | 01/09/2018SE |
More from Pharmaceutical Innovations, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K040679 | Rich-Mar Autoprism Infrared LampILY · Traditional | 05/07/2004SE |
| 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 |
| K950564 | Rich-Mar Us-Ii UltrasoundIMI · Traditional | 05/15/1995SE |
Questions and answers
When was Autogel Pad cleared by the FDA?
Autogel Pad (K031018) received a 510(k) decision of Substantially Equivalent on December 8, 2003, 252 days after the submission was received.
What is the product code of K031018?
The FDA product code is MUI – Media, Coupling, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 892.1570.