Senergy Medical Group | Government Certifications & Contractors

Medical Equipment and Supplies
FSC Group 65, Part II, Section A
FSC Class: 6515

Contract Number: V797D – 50488
Contract Period: October 1, 2015 to September 30, 2020

On-line access to contract ordering information, terms and conditions, up-to-date pricing, and the option to create an electronic delivery order are available through GSA Advantage!™, a menu-driven database system. The INTERNET address for GSA Advantage! ™ is GSAAdvantage.gov

For more information on ordering from Federal Supply Schedules, enter the following address
into your web browser: http://gsa.gov/portal/category/100623

Authorized Contractor

MARTEN GROUP, INC DBA: SENERGY MEDICAL GROUP
9901 Valley Ranch Pwky E
Ste 1009
Irving, TX 75063
Phone #: 972-580-0545
Fax: 214-260-7765
www.senergy.us

Business Size: Small

 

To Download and Print
Contractor: Marten Group, Inc DBA: Senergy Medical Group
Capability Statement and Authorized Federal Supply Price List

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Tennant BioModulator® PLUS and PRO Certifications

Certifications

  • ISO-13485 Quality Certified – Medical Products
  • CE Approved in Europe – Microcurrent, Biofeedback Device
  • CB Safety Certified – Meet Safety Standards IEC 60601-1, 60601-1-2 TENS

Government Clearance

  • FDA cleared for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment in the management of post-surgical and post-traumatic pain (available by prescription only).
  • HealthCanada cleared as a microcurrent, biofeedback device for muscle training and re-education, electrical nerve stimulation, improved circulation, improved range of motion; and, management of chronic pain, intractable pain, post-surgical pain and traumatic pain

FDA Compliance

Tennant Biomodulator Slimline Plus® device and accessories are US FDA cleared as Biofeedback micro-current TENS devices indicated for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post- traumatic pain. US Federal law restricts these devices to sale by or on the order of a physician.

  • CFR 21 Sec. 882.5050 Biofeedback device (a) Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient’s physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.)so that the patient can control voluntarily these physiological parameters. (b) Classification. Class II (special controls).The device is exempt from pre-market notification procedures in subpart E of part 807 of this chapter when it is a prescription battery-powered device that is indicated for relaxation training and muscle re-education and prescription use, subject to 882.9.
 
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