RS-1 Neuromuscular Stimulator
FDA 510(k) K920388 · Rs Medical
510(k) numberK920388
Submission
- Device name
- RS-1 Neuromuscular Stimulator
- Applicant
- Rs Medical
Washington, DC, US - Received
- January 30, 1992
- Decision date
- January 28, 1993
- 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 |
|---|---|---|
| K112348 | RS-4I Muscle StimulatorIPF · Special | 01/19/2012SE |
| K090951 | Rs- LB Low Back Conductive Garment, Model Rs-Lbm, Rs-Lbl, Rs-Fbg Full Back Conductive…GXY · Traditional | 06/05/2009SE |
| K062325 | RS-4I Muscle Stimulator FamilyNYN · Traditional | 04/13/2007SE |
| K032652 | RS-4I Muscle Stimulator FamilyIPF · Traditional | 09/12/2003SE |
| K021763 | RS2MI Muscle Stimulator FamilyIPF · Traditional | 06/13/2002SE |
| K000114 | RS-4M+MUSCLE StimulatorIPF · Traditional | 08/10/2000SE |
| K990697 | RS-4V Muscle StimulatorIPF · Traditional | 06/18/1999SE |
| K953136 | RS-4MIPF · Traditional | 11/30/1995SN |
| K920389 | RS-2 Neuromuscular StimulatorIPF · Traditional | 01/28/1993SE |
Questions and answers
When was RS-1 Neuromuscular Stimulator cleared by the FDA?
RS-1 Neuromuscular Stimulator (K920388) received a 510(k) decision of Substantially Equivalent on January 28, 1993, 364 days after the submission was received.
What is the product code of K920388?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.