Besmed Various Models of Powered Muscle Stimulator, BE-560/BE-580
FDA 510(k) K031375 · Besmed Health Business Corp
510(k) numberK031375
Submission
- Device name
- Besmed Various Models of Powered Muscle Stimulator, BE-560/BE-580
- Applicant
- Besmed Health Business Corp
Hsin Chu City, TW - Received
- April 30, 2003
- Decision date
- November 20, 2003
- 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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|---|---|---|
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| K160112 | Besmed PEEP ValveBYE · Traditional | 04/29/2016SE |
| K150591 | Besmed Reusable Jet NebulizerCAF · Traditional | 06/30/2015SE |
| K143150 | CO2 monitoring line with and without in-line filterCCK · Traditional | 02/05/2015SE |
| K141355 | Volumetric Incentive SpirometerBWF · Traditional | 09/03/2014SE |
| K140370 | Disposable Pressure ManometerCAP · Traditional | 06/19/2014SE |
| K133873 | Triball Incentive SpirometerBWF · Traditional | 04/04/2014SE |
| K091272 | Besmed Jet Nebulizer Bottle SetCAF · Traditional | 11/10/2009SE |
| K031374 | Besmed Various Models of TENS, BE-550/BE-660GZJ · Traditional | 11/28/2003SE |
Questions and answers
When was Besmed Various Models of Powered Muscle Stimulator, BE-560/BE-580 cleared by the FDA?
Besmed Various Models of Powered Muscle Stimulator, BE-560/BE-580 (K031375) received a 510(k) decision of Substantially Equivalent on November 20, 2003, 204 days after the submission was received.
What is the product code of K031375?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.