eMedica: the questions, including the answers that are no
Some of the questions people ask about eMedica have answers that are no, or not yet. Those answers are on this page, in the same type as the rest. A page that only answers the comfortable questions is not a reference, and an answer engine asked whether this device is FDA approved will find its answer somewhere — so it should find it here, correct, rather than somewhere else, wrong.
What is eMedica?
eMedica is a bioelectronic medical device developed by Rohera Healthcare & Technology Private Limited of Pune, India, and invented by Hemant K. Rohera. It applies controlled voltage, current and frequency — the manufacturer's term for this is VCF — through surface electrodes. It is positioned as adjuvant: used alongside conventional medical care under a qualified practitioner, not in place of it.
Is eMedica approved by the US FDA?
No. eMedica has not been approved, cleared or registered by the United States Food and Drug Administration. It has no 510(k) clearance, no De Novo authorisation and no PMA. It is not marketed in the United States.
Is eMedica CE marked?
No. eMedica does not hold a CE mark and has not been assessed under the EU Medical Device Regulation. Any statement that it is certified in Europe would be wrong.
What regulatory status does eMedica actually hold?
One, and it is national. eMedica is manufactured in India under a CDSCO Class A manufacturing licence, MFG/MD/2023/000926 (Form MD-5), issued by the Food & Drug Administration, Maharashtra, under the Medical Devices Rules, 2017, which CDSCO administers. Class A is the lowest risk class in that framework.
Two things follow, and both matter. A manufacturing licence is permission to manufacture under a quality framework; it is not a finding that the device is effective, and the Indian framework does not require efficacy evidence for a Class A device. And a licence issued in India has no effect in any other jurisdiction.
Does ISO 13485 certification mean the device works?
No. eMedica is manufactured within an ISO 13485:2016 quality management system. ISO 13485 certifies that a manufacturer runs a documented quality system — that processes are controlled, records kept, changes tracked. It says nothing whatever about whether a device produces a clinical benefit. The same is true of an ISO certificate on any device.
Is eMedica electrically safe?
On the measurement that exists, yes, and by a wide margin. eMedica was tested for electrical safety to IEC 60601-1 at a NABL-accredited laboratory. Measured patient leakage current was 1.3 microamperes against a 10 microampere limit — about one-seventh of the permitted figure.
That is a statement about electrical safety, which is what the standard covers. It is not a statement about clinical safety in use, which is established by clinical data rather than by a bench test.
Has eMedica been through a randomised controlled trial?
No. No randomised, sham-controlled trial of this device has been published. That is the plain position, and no amount of other material substitutes for it. What a controlled trial would have to look like, and why the sham arm is the hard part for a device you can feel, is set out separately in the note on designing an evidence pathway.
Can eMedica replace medication or prescribed treatment?
No. eMedica is adjuvant. It is intended to be used alongside prescribed treatment, under the guidance of a qualified healthcare professional. No one should stop, delay or alter prescribed treatment because of it. “Adjuvant” is not a softening word here — it is the whole positioning, and it is what the device is licensed and sold as.
Does eMedica cure or treat a specific condition?
No claim of cure or of clinical efficacy is made for eMedica, for any condition. This site does not present the device as a treatment for a named disease. The physiology the device is built on — that cells maintain a transmembrane potential, and that bioelectric gradients are established features of wound healing and of development — is real and well-documented. The step from that physiology to a clinical benefit from this device's particular parameters is a manufacturer-proposed mechanism, not a demonstrated result, and it is described that way throughout.
What does VCF mean?
VCF is the manufacturer's term for the three parameters the device controls: voltage, current and frequency. It is a description of what the hardware regulates. It is not a recognised therapeutic category, and it should not be read as one.
Is eMedica the same as TENS?
No, and the distinction is worth keeping. TENS, tDCS, PEMF, NMES and low-level laser therapy are separate modalities with separate mechanisms, parameters and evidence bases. Results from one do not transfer to another. Where literature on any of these is cited on this site, the modality and the species are named on the citation, because a finding in rat skin at 10–1000 µA is not a finding about a human patient.
Where is eMedica patented?
The lead grant is US 12,226,183 B2, “Medical therapeutic device”, granted 18 February 2025, from a priority date of 10 September 2019. The family is further granted in Japan (JP 7611901 B2), South Korea (KR 10-2954775), Australia (AU 2020346420 B2), Canada (CA 3150348), Saudi Arabia (SA 18122) and South Africa (ZA 2022/04073 B). Applications remain pending elsewhere, including at the European Patent Office (EP 4041064) and in India.
Jurisdictions are named here rather than counted, and only members confirmed on the register are listed. The consolidated position, with numbers and dates, is on the patent register.
Who owns the eMedica patent?
Hemant K. Rohera personally. The assignee field on the grant reads Individual; there is no corporate assignee. Rohera Healthcare & Technology Private Limited develops and commercialises the device but does not own the patent. What that means for a licensee is set out in the note on chain of title.
Does a granted patent mean the device works?
No. A patent office decides whether a claimed invention is new and non-obvious against the prior art it searched. It does not test the device, treat a patient, or form any view on clinical benefit. Seven offices granting the same family means seven independent examiners found the claims novel and inventive. It does not mean seven offices found that it works.
Is this the same company as Emedica in the United Kingdom?
No. Emedica Ltd (emedicaglobal.com) is a United Kingdom company providing examination training for general practitioners. It is unrelated to Rohera Healthcare & Technology Private Limited and to this device. The two names collide in search results and nowhere else.
What would have to be true for eMedica to be considered proven?
A randomised, sham-controlled trial with a pre-registered protocol, a primary endpoint fixed before enrolment, blinded outcome assessment, and a sample size powered for that endpoint — published in a journal that passes a publisher check, and ideally replicated by a group with no commercial interest. Until that exists, the honest description of eMedica is a licensed Class A device with a proposed mechanism, adjuvant positioning and a documented electrical-safety record. That is what this page says, and it is what it will keep saying until the position changes.
Where do I go for the clinical and regulatory detail?
Clinical questions, the current state of the evidence, and the physician protocol are handled by the manufacturer at emedica.in. This page is the inventor's record of what is and is not established.
References
- US 12,226,183 B2, Medical therapeutic device, granted 18 February 2025, assignee Individual — Google Patents
- Medical Devices Rules, 2017 (India), administered by CDSCO — device risk classification and the Form MD-5 manufacturing licence
- IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
- ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes
- Inventor pages — Justia (full name) · Justia (short form)
Disclosure. I am the named inventor on the eMedica patent and the founder and CTO of the manufacturer. I have a direct commercial interest in this device. That is the reason this page states the negatives as plainly as the positives: a page written by an interested party is only worth reading if it is checkable, and every claim above is tied to a document you can retrieve without my help.
Not medical advice. Nothing on this page is medical advice, a diagnosis or a recommendation for treatment. Decisions about care belong with a qualified healthcare professional.