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FDA PMA

Diagnostic low electric field

PMA Number: P110014 · 2025-09-17

ApplicantDilon Medical Technologies, Ltd.
Decision Date2025-09-17
PMA NumberP110014
Product CodeOEE
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeSU

Device Summary

Diagnostic low electric field is the device name listed in this FDA PMA record. The listed applicant is Dilon Medical Technologies, Ltd.. It received FDA Premarket Approval (PMA) on 2025-09-17 under PMA number P110014. The device is classified under FDA product code OEE. It was reviewed by the SU advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Diagnostic low electric field?

Diagnostic low electric field is a medical device that received FDA Premarket Approval (PMA) on 2025-09-17. The listed applicant is Dilon Medical Technologies, Ltd.. The PMA number is P110014.

When did Diagnostic low electric field receive FDA PMA approval?

Diagnostic low electric field received FDA PMA approval on 2025-09-17, under PMA number P110014.

Who is the listed applicant for Diagnostic low electric field?

The FDA PMA record lists Dilon Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Diagnostic low electric field?

The FDA product code for Diagnostic low electric field is OEE.

What FDA device class is Diagnostic low electric field?

Diagnostic low electric field is classified as Class III by the FDA.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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