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RGR Medical Solutions Inc

RGR Medical Solutions Inc. is a medical device manufacturer. We make NeuroZenn a revolutionary pain management device for those suffering with chronic pain.
About Us

RGR Medical Solutions Inc

RGR Medical Solutions Inc. is a medical device manufacturer. We make NeuroZenn a revolutionary pain management device for those suffering with chronic pain.
Why Choose Us

Why Choose NeuroZenn

This allows the patient to be active in their daily activities and continue to have a higher quality of life instead of sitting down during a therapy session like our competitors. The unit comes with two electrodes which are needed to operate the brain box and need to be changed about every two weeks (14 days). Once a patient has begun therapy, they will need a monthly set of two electrodes to continue therapy sessions.

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.