RGR Medical Solutions, Inc.

Welcome to RGR Medical Solutions, where innovation meets compassion.

Contact us today to learn more about NeuroZenn, a groundbreaking alternative to opioids that provides sustained relief from chronic pain in as few as 10 minutes. Your patients will thank you.

RGR Medical Solutions, Inc.

Since our founding in November 2014, RGR Medical Solutions, Inc. has been a leading manufacturer of medical devices. We are dedicated to revolutionizing pain management with innovative solutions designed to improve patient well-being. Our commitment is to provide safe, effective, and sustainable pain management options for every patient. 

Join us in shaping the future of pain relief.

Why NeuroZenn?

We are proud to present NeuroZenn, a cutting-edge, wearable medical device for the treatment of chronic pain. In an era where opioid addiction poses significant risks, NeuroZenn offers a safe alternative for pain management.

Key Benefits of NeuroZenn:

  • Significant, sustained pain relief in as few as 10 minutes. 
  • Avoids risks associated with Opioid Dependency: Provides effective pain relief without the dangers and addiction risks associated with opioid treatments.
  • Effective and Non-Invasive: Delivers significant and lasting pain reduction through non-invasive means, enhancing patient safety and comfort.
  • Enhanced Quality of Life: Allows patients to engage in daily activities, including work and personal time, with minimal pain interference.
  • Sustained Relief: Offers reliable, continuous pain relief, improving overall well-being.
  • Convenient: Battery-operated with a recharge needed only every two weeks, ensuring continuous pain management.

NeuroZenn empowers your patients to manage their pain safely and effectively, helping to combat the opioid crisis. Join us in providing a safer, healthier alternative for chronic pain management and support your patients in reclaiming their lives.

Journal References:

Neuromuscular electrical stimulation to improve exercise capacity in patients with severe COPD: a randomized double-blind, placebo-controlled trial; Matthew Maddocks; Lancet Respiratory Medicine 2016; 4:27-36.

Babber A, Ravikumar R, Onida S, Lane TRA, Davies AH. Effect of footplate neuromuscular electrical stimulation on functional and quality-of-life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial. Br J Surg. 2020;107(4):355-363. doi:10.1002/bjs.11398.

Ravikumar R, Williams KJ, Babber A, Lane TRA, Moore HM, Davies AH. Randomised Controlled Trial: Potential Benefit of a Footplate Neuromuscular Electrical Stimulation Device in Patients with Chronic Venous Disease. Eur J Vasc Endovasc Surg. 2017;53(1):114-121. doi:10.1016/j.ejvs.2016.09.015.

Jarit, G. J., Mohr, K. J., Waller, R., Glousman, R. E., The Effects of Home Interferential Therapy on Post-Operative Pain, Edema, and Range of Motion of the Knee.  Clin J Sport Med. 2003 Jan;13(1):16-20.  DOI: 10.1097/00042752-200301000-00004

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VOLUME 2, ISSUE 5, P295-300, OCTOBER 01, 2001

Electrical muscle stimulation as an adjunct to exercise therapy in the treatment of nonacute low back pain: A randomized trial

DOI:https://doi.org/10.1054/jpai.2001.25523

Electrical muscle stimulation as an adjunct to exercise therapy in the treatment of nonacute low back pain: a randomized trial

Glaser, J.A., Baltz, M.A., Nietert, P.J., Bensen, C.V., Electrical Muscle Stimulation as an Adjunct to Exercise Therapy in the Treatment of Nonacute Low Back pain: a Randomized Trial. J Pain

. 2001 Oct;2(5):295-300.

doi: 10.1054/jpai.2001.25523.

Armstrong, D. G. and Lavery, L.A., Is Electrical Stimulation Effective in Reducing Neuropathic Pain in Patients with Diabetes?  The Journal of Foot and Ankle Surgery, 36(4): 260-263, 1997.

Peters, E.J.G., Armstrong D. G., Wunderlick, R.P., Bosma, J., Stacpoole-Shea, S., and Lavery, L.A., The Benefit of Electrical Stimulation to Enhance Perfusion in Persons with Diabetes Mellitus, The Journal of Foot and Ankle Surgery.  Sep-Oct 1998;37(5):396-400; discussion 447-8.

Peters, E.J.G., Lavery, L.A., Armstrong, D.G., Fleischli, J.G., Electric Stimulation as an Adjunct to Heal DIanbetic Foot Ulcers: A randomized Clinical Trial.  Arh Phsy Med Rehabil vol 82, June 2001.

Device Classification Name

Stimulator, Neuromuscular, External Functional

510(K) Number

K153163

Device Name

ReGrasp

Applicant

Rehabtronics Inc.

#4532, 10230 Jasper Avenue

Edmonton,  CA T5j 4p6

Applicant Contact

Mike Pearson

Correspondent

Rehabtronics Inc.

#4532, 10230 Jasper Avenue

Edmonton,  CA T5j 4p6

Correspondent Contact

Mike Pearson

Regulation Number

882.5810

Classification Product Code

GZI  

Subsequent Product Code

IPF  

Date Received

11/02/2015

Decision Date

04/07/2016

Decision

Substantially Equivalent (SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Statement

Statement

Type

Traditional

Reviewed By Third Party

No

Combination Product

No

DEVICE DESCRIPTION Prizm Medical, Inc. Micro-ZTM Stimulation System is a compact battery operated transcutaneous electrical stimulator that delivers a micro-current to the surface area of our patented conductive Silver-Thera E.M. garment electrodes to provide electrical stimulation for chronic or intractable pain (see indications for use statement). It is designed not to exceed 100 volts across the garment electrodes. The technical Specifications for the MicroZTM Stimulator can be found in Appendix A. The stimulator is wearable with the Velcro@ strip that attaches the device to the Velcro@ dleg strap. It is microprocessor controlled, allowing for easy setup of the treatment parameters and precise control of each setting with a garment electrode dedicated to the upper or lower extremities. The system incorporates a proprietary connection from the stimulator to the electrodes that renders the device unusable without the dedicated electrodes. It is designed for ease of patient use with clearly marked patient intensity buttons. Please refer to the Operations Manual (Exhibit A) for photographs and a more thorough description of the device. The Prizm Medical, Inc. Micro-ZTM Stimulation System is intended for the symptomatic relief and management of chronic (long-term) intractable (not easily controlled) pain and to help with the management of post surgical and post-traumatic acute pain problems. The primary function of the Micro-ZTM Stimulation System is the same as the Empi Focus and raises no new questions of safety and effectiveness.