Regulatory & Patents

Regulatory:

U.S. FDA 510(K) no. K052836 clearance to market in the U.S.  No. K131675 received Feb. 11, 2014  EPRT BodiHealth TENS System with Silver Wrap
TGA (Therapeutic Goods Administration) Registration in Australia, inclusion number ARTG No. 152316.
CE Mark Certification No. 41316067 Full quality assurance system
EPRT Technologies, Inc. is ISO 13485:2003 Compliant InterTek Certificate No 9584

Indications for Use:

“The BodiHealth Device is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic pain”.

Manufacturing:

Digi-Com Electronics, the San Francisco-based manufacturing partner for EPRT Technologies, is an ISO 13485/2008 certified manufacturing facility. It has operated as our FDA-registered and California-licensed medical device manufacturer since 2003.

Patents:

  • United States Patent Issued, No.: US 9,421,367 B1
  • PCT/European Patent: “Method & Apparatus for Performing MicroCurrent Electrotherapy”
  • AU & NZ Patent: “Method & Apparatus for Performing MicroCurrent Electrotherapy”
  • AU provisional patent applications: Treatment of Hypertension & Treatment of Diabetes