CyMedica e-vive System; CY-1000
FDA 510(k) K163067 · Cymedica Orthopedics, Inc.
510(k) numberK163067
Submission
- Device name
- CyMedica e-vive System; CY-1000
- Applicant
- Cymedica Orthopedics, Inc.
Scottsdale, AZ, US - Received
- November 2, 2016
- Decision date
- December 1, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
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| K251083 | Compact IIIPF · Traditional | Enraf-Nonius, B.V. | 09/12/2025SE |
| K241433 | EVE Synergy (EVE-20M)IPF · Traditional | Weero Co., Ltd. | 06/04/2025SE |
| K241488 | TrainFES AdvanceIPF · Traditional | Trainfes | 02/05/2025SE |
| K240348 | Quantum Mitohormesis (QMT) (M2101)IPF · Abbreviated | Quantumtx Pte. , Ltd. | 12/19/2024SE |
| K240992 | eMVFit (MVF-10M)IPF · Traditional | Weero Co., Ltd. | 10/10/2024SE |
| K240234 | BTL-899MSIPF · Traditional | BTL Industries, Inc. | 08/17/2024SE |
| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | Sunmed, LLC | 08/02/2024SE |
More from Sunmed, LLC
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| K230533 | Motive ElectrodeGXY · Traditional | 03/22/2023SE |
| K220738 | Motive Knee WrapIPF · Traditional | 05/12/2022SE |
| K210604 | Intellihab SystemIPF · Traditional | 06/03/2021SE |
| K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorIPF · Traditional | 04/02/2015SE |
Questions and answers
When was CyMedica e-vive System; CY-1000 cleared by the FDA?
CyMedica e-vive System; CY-1000 (K163067) received a 510(k) decision of Substantially Equivalent on December 1, 2016, 29 days after the submission was received.
What is the product code of K163067?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.