Vectra Neo Clinical Therapy System
FDA 510(k) K132284 · Djo, LLC
510(k) numberK132284
Submission
- Device name
- Vectra Neo Clinical Therapy System
- Applicant
- Djo, LLC
Vista, CA, US - Received
- July 23, 2013
- Decision date
- April 10, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
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| 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 |
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| K170903 | Compex Wireless USANGX · Traditional | 06/19/2017SE |
| K153704 | StriveGZJ · Abbreviated | 06/03/2016SE |
| K153696 | Chattanooga Revolution WirelessIPF · Traditional | 04/14/2016SE |
| K153224 | VitalStim(R) Plus Electrotherapy SystemIPF · Traditional | 02/17/2016SE |
| K143551 | Compex Wireless USANGX · Traditional | 04/28/2015SE |
| K130722 | Aircast Venaflow Elite SystemJOW · Traditional | 06/20/2013SE |
| K124016 | Empi PhoenixIPF · Abbreviated | 05/06/2013SE |
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Questions and answers
When was Vectra Neo Clinical Therapy System cleared by the FDA?
Vectra Neo Clinical Therapy System (K132284) received a 510(k) decision of Substantially Equivalent on April 10, 2014, 261 days after the submission was received.
What is the product code of K132284?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.