Ness L300
FDA 510(k) K053468 · Ness-Neuromuscular Electrical Stimulation Systems
510(k) numberK053468
Submission
- Device name
- Ness L300
- Applicant
- Ness-Neuromuscular Electrical Stimulation Systems
Washington, DC, US - Received
- December 13, 2005
- Decision date
- July 7, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Guangzhou Longest Science & Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K111767 | Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican KitGZI · Traditional | 09/15/2011SE |
| K080219 | Modification To:Ness L300GZI · Special | 02/28/2008SE |
| K031900 | HandmasterGZI · Special | 08/08/2003SE |
| K024279 | Ness Children SystemIPG · Traditional | 02/05/2003SE |
| K022776 | Ness SystemIPF · Special | 09/11/2002SE |
| K012823 | Modification to HandmasterGZI · Traditional | 11/14/2001SE |
Questions and answers
When was Ness L300 cleared by the FDA?
Ness L300 (K053468) received a 510(k) decision of Substantially Equivalent on July 7, 2006, 206 days after the submission was received.
What is the product code of K053468?
The FDA product code is GZI – Stimulator, Neuromuscular, External Functional, a Class II (moderate risk) device regulated under 21 CFR 882.5810.