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Regenesis Model 42

FDA 510(k)

Class II (US FDA 510(k))

510(k) K972093

by Regenesis Biomedical, Inc.

Identifiers

510(k) Number
K972093 FDA 510(k)
FDA Product Code
ILX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5290 FDA 510(k)
Regulation Number
890.5290 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Regenesis Model 42 is a Shortwave Diathermy Device (Class II) designed for use other than applying therapeutic deep heat. It delivers pulsed short-wave energy to promote tissue healing and reduce inflammation in physical medicine applications, as classified under FDA product code ILX. This device operates outside the frequency range used for deep heating, targeting superficial or localized tissue stimulation.

The device consists of a main control console connected to a waterproof, bacterial-resistant treatment pad via cable. It is intended for single-use or reusable application, either placed directly on the patient or over standard dressings, and is not MRI-compatible. Supplied as a sterile or non-sterile unit depending on clinical protocol, it requires proper storage to maintain functionality. Authorized under FDA 510(k) clearance (K972093), it adheres to regulatory standards for shortwave diathermy devices in physical medicine settings.

Frequently asked questions

What specific medical conditions or applications is the Regenesis Model 42 intended to address in physical medicine settings?

The Regenesis Model 42 is designed for use in physical medicine to promote tissue healing and reduce inflammation through pulsed short-wave energy. Unlike traditional deep-heating diathermy, it targets superficial or localized tissue stimulation, making it suitable for applications where controlled energy delivery is needed to support recovery or alleviate localized discomfort.

How is the Regenesis Model 42 supplied, and can it be reused or is it single-use?

The Regenesis Model 42 is supplied as either a sterile or non-sterile unit, depending on clinical protocol requirements. It is intended for single-use or reusable application, meaning the treatment pad can be used multiple times if properly cleaned and maintained, or replaced as a sterile unit when needed. The device’s waterproof and bacterial-resistant pad design supports reuse under appropriate hygiene protocols.

What storage requirements should be followed to ensure the Regenesis Model 42 remains functional?

The Regenesis Model 42 requires proper storage to maintain its functionality, particularly if used in a reusable setting. While the exact storage conditions aren’t detailed, typical shortwave diathermy devices should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. If the pad is reusable, it should be cleaned and dried thoroughly between uses to prevent bacterial buildup and ensure longevity.

Is the Regenesis Model 42 compatible with MRI machines, and how should it be handled in an MRI environment?

No, the Regenesis Model 42 is not MRI-compatible. It should never be brought into an MRI environment due to the risk of interference with magnetic fields or potential damage to the device. If used in a facility with MRI capabilities, ensure the device is stored separately and only transported to non-MRI areas for patient treatment.

What regulatory pathway was followed for FDA clearance of the Regenesis Model 42, and what does this mean for clinicians?

The Regenesis Model 42 received FDA clearance through a Traditional 510(k) pathway, classified as substantially equivalent to a predicate device under product code ILX (Physical Medicine). This means the device was reviewed by the FDA’s Physical Medicine (PM) Advisory Committee and determined to meet safety and effectiveness standards for its intended use in promoting tissue healing and reducing inflammation. Clinicians can rely on this clearance as evidence of regulatory scrutiny for its designated applications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: REGENESIS MODEL 42 (K972093) — FDA 510 (k) | Innolitics, Regenesis Model 42 510 (k) FDA Premarket Notification K972093 REGENESIS ..., PDF K972093 REGENESIS MODEL 42 - 510kdatabase.net, Regenesis Biomedical, Inc. FDA 510 (k) Products 2023

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Regenesis Biomedical, Inc.

Sources (1)

  • FDA 510(k) K972093 24 fields · synced Sep 20, 2026