Bioness indications
WebIndications for Use. The Bioness Integrated Therapy System (BITS) is intended to challenge and assess the physical, visual, auditory, and cognitive abilities of individuals, … WebIndividual results may vary. Consult with a qualified physician to determine if these products are right for you. Important Safety Information and Risks: For Indications for Use, Contraindications, Warnings, Adverse Reactions, Precautions, and other safety information please refer to the L300 Go User Guide.. L300 Go®, myBioness™, Bioness, the …
Bioness indications
Did you know?
WebPurpose of the 510(k) To modify the indications for use Predicate devices 1. NESS (Neuromuscular Electrical Stimulation Systems) Ltd. (currently known as Bioness … WebMar 30, 2024 · Bioness innovations have been implemented in many of the most prestigious and well-respected institutions around the globe with 17 of the top 20 rehabilitation hospitals in the United States currently using one or more Bioness solutions. ... line extensions or expanded indications by physicians, patients, third-party payers …
Web22. 510 (k) Number. K142432. Device Name. StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit. Applicant. BIONESS, INC. 25103 RYE CANYON LOOP. VALENCIA, CA 91355. WebUse only Bioness components with your StimRouter system. Use of non-Bioness components may damage the system and cause injury. ... For indications for use, …
WebBioness L300 Foot Drop System. Helps those with neurological conditions walk naturally, with improved speed and balance. The L300’s advanced technology delivers programmed, low-level electrical stimulation to activate nerves and muscles that lift the foot and allow for increased mobility. The NESS L 300 Plus specifically provides ankle ... WebThe StimRouter ® peripheral nerve stimulation system created by Bioness, Inc., (CA, USA) is US FDA-approved for the treatment of peripheral mononeuropathy refractory to …
WebIndications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2024 See PRA Statement below. 510(k) Number (if known) K173682 Device Name L300 Go System Indications for Use (Describe) The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or to
WebBioness provides this information for your convenience only. It is the responsibility of the provider to determine coverage and to manage billing codes, including modifiers, and charges for the rendered service. Bioness provides assistance for FDA cleared indications under 510(k) K142432, K190047 and K200482 only. floating vs glue down lvtWebCompany: Bioness Inc. 25103 Rye Canyon Loop Valencia, CA 91355 USA Phone Number: (661) 388-9303 Fax: (661) 362-4851 Email: [email protected] Contact: Sageev George Senior Regulatory Affairs Manager, Implantables Bioness Inc. Phone Number: (661) 388-9303 Fax Number: (661) 362-4851 Email: [email protected] … floating votive candlesWebMar 30, 2024 · Bioness innovations have been implemented in many of the most prestigious and well-respected institutions around the globe with 17 of the top 20 … floating vs glue down lvpWebBioness devices are clinically proven with the ability to increase range of motion and reduce the risk of falls, while improving confidence and independence. 1,2 . L300 Go Lower Cuff. ... Indications for Use, Contraindications, Warnings, Adverse Reactions and Precautions, ... great lakes cruises for seniors near meWebMay 7, 2012 · Bioness® StimRouter™ Neuromodulation System for Chronic Pain Therapy The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. floating vs fixed exchange rate systemWebIndications for Use. The Bioness Integrated Therapy System (BITS) is intended to challenge and assess the physical, visual, auditory, and cognitive abilities of individuals, including those with deficits resulting from traumatic injuries and movement disorders as well as competitive athletes. Examples of these abilities include: floating vs granted ptogreat lakes cruises from chicago to toronto