Strive
FDA 510(k) K153704 · Djo, LLC
510(k) numberK153704
Submission
- Device name
- Strive
- Applicant
- Djo, LLC
Vista, CA, US - Received
- December 23, 2015
- Decision date
- June 3, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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| K232441 | Unipro (K-UNIPRO-US)GZJ · Traditional | Tenscare, Ltd. | 08/30/2024SE |
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| K233046 | Electrical Neuromuscular Stimulator, Cure TrioGZJ · Traditional | Oriental Inspiration Limited | 04/19/2024SE |
| K222879 | Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)GZJ · Traditional | Wuxi Jiajian Medical Instrument Co., Ltd. | 01/24/2023SE |
| K212618 | iRelieve Microcurrent Pain Relief SystemGZJ · Traditional | Fast Track Technologies, Inc. | 09/14/2022SE |
| K213802 | StimOnTM Pain Relief System (GM2439)GZJ · Traditional | Gimer Medical Co., Ltd. | 08/26/2022SE |
| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)GZJ · Traditional | Bozhou Rongjian Medical Appliance Co., Ltd. | 05/25/2022SE |
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| K130722 | Aircast Venaflow Elite SystemJOW · Traditional | 06/20/2013SE |
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Questions and answers
When was Strive cleared by the FDA?
Strive (K153704) received a 510(k) decision of Substantially Equivalent on June 3, 2016, 163 days after the submission was received.
What is the product code of K153704?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.