Ness System
FDA 510(k) K022776 · Ness-Neuromuscular Electrical Stimulation Systems
510(k) numberK022776
Submission
- Device name
- Ness System
- Applicant
- Ness-Neuromuscular Electrical Stimulation Systems
Washington, DC, US - Received
- August 21, 2002
- Decision date
- September 11, 2002
- 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
Other 510(k)s with product code IPF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M)IPF · Traditional | Weero Co., Ltd. | 06/08/2026SE |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
| K260142 | StimelMD (SSMD) systemIPF · Special | Motion Informatics ltd. | 05/27/2026SE |
| 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
| 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 |
| K053468 | Ness L300GZI · Traditional | 07/07/2006SE |
| K031900 | HandmasterGZI · Special | 08/08/2003SE |
| K024279 | Ness Children SystemIPG · Traditional | 02/05/2003SE |
| K012823 | Modification to HandmasterGZI · Traditional | 11/14/2001SE |
Questions and answers
When was Ness System cleared by the FDA?
Ness System (K022776) received a 510(k) decision of Substantially Equivalent on September 11, 2002, 21 days after the submission was received.
What is the product code of K022776?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.