Neuromuscular Electrical Stimulator, Model EV-807P
FDA 510(k) K033140 · Everyway Medical Instruments Co.,Ltd
510(k) numberK033140
Submission
- Device name
- Neuromuscular Electrical Stimulator, Model EV-807P
- Applicant
- Everyway Medical Instruments Co.,Ltd
Alpharetta, GA, US - Received
- September 30, 2003
- Decision date
- October 29, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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
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| K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4NUH · Special | 11/21/2025SE |
| K222488 | Everyway Analog OTC TENSNUH · Traditional | 11/15/2022SE |
| K213116 | Everyway Incontinence Stimulation SystemKPI · Traditional | 12/03/2021SE |
| K202849 | Everyway Analog OTC TENS, model N103A/N302NUH · Traditional | 12/22/2020SE |
| K202470 | Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300NUH · Traditional | 11/25/2020SE |
| K202317 | Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806NUH · Traditional | 11/13/2020SE |
| K201335 | Li-Battery powered OTC TENS/EMS Combination StimulatorNUH · Traditional | 10/24/2020SE |
| K192589 | Everyway OTC TENS/EMS CombinationNUH · Traditional | 12/19/2019SE |
| K182767 | V2 OTC Pain Relief TENSNUH · Special | 10/26/2018SE |
| K182753 | A6 OTC Pain Relief TENSNUH · Special | 10/26/2018SE |
Questions and answers
When was Neuromuscular Electrical Stimulator, Model EV-807P cleared by the FDA?
Neuromuscular Electrical Stimulator, Model EV-807P (K033140) received a 510(k) decision of Substantially Equivalent on October 29, 2003, 29 days after the submission was received.
What is the product code of K033140?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.