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sensiFirm

FDA 510(k)

Class II (US FDA 510(k))

510(k) K170637

by El Global Trade Ltd

Identifiers

510(k) Number
K170637 FDA 510(k)
FDA Product Code
PBX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The sensiFirm is a Vacuum, Radio Frequency Induced Heat Massager, designed to deliver targeted thermal and mechanical stimulation to soft tissue. It combines radiofrequency energy with vacuum suction to address localized skin concerns, including temporary improvements in cellulite appearance.

This device is intended for over-the-counter home use and is supplied as a reusable, non-sterile system. It operates under FDA 510(k) clearance (K170637) and complies with 21 CFR 878.4400 for Class II medical devices. The device requires no special storage conditions and is intended for use in non-clinical settings, such as home environments.

Frequently asked questions

Is the sensiFirm device intended for clinical use in a healthcare setting, or is it designed for home use only?

The sensiFirm is explicitly designed for over-the-counter home use and is not intended for clinical or professional healthcare settings. Its regulatory classification under 21 CFR 878.4400 and FDA 510(k) clearance (K170637) confirm its intended use in non-clinical environments, such as personal use at home.

How many different models or sizes of the sensiFirm device are available, and how are they differentiated?

The sensiFirm comes in multiple models, as indicated by the extensive list of registration numbers (e.g., 3030420005, 3002808227, etc.) under the OpenFDA entry. While the exact specifications for each model aren’t detailed here, these registration numbers likely correspond to variations in design, attachments, or intensity levels for targeted use. The manufacturer would provide further clarification on how these models differ.

Does the sensiFirm require any special storage conditions, or can it be kept at room temperature?

No special storage conditions are required for the sensiFirm. The device is explicitly stated to be intended for use in non-clinical settings without mention of temperature, humidity, or other environmental constraints, meaning it can be stored at room temperature.

Is the sensiFirm device reusable, or is it intended for single-use only?

The sensiFirm is described as a reusable system, meaning it is not designed for single-use. However, it is also noted as non-sterile, so proper cleaning and maintenance per manufacturer guidelines are necessary to ensure safe, repeated use.

What is the intended purpose of the radiofrequency and vacuum suction features in the sensiFirm?

The radiofrequency and vacuum suction features in the sensiFirm are combined to deliver targeted thermal and mechanical stimulation to soft tissue. According to the description, this is designed to address localized skin concerns, specifically to provide temporary improvements in the appearance of cellulite. The device leverages these technologies to enhance circulation and tissue firmness.

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: SENSIFIRM OTC Home Use Device... - FCC ID 2ABRVSENSIFIRM, FCC ID 2ABRVSENSIFIRM - OTC Home Use Device, El Global Trade LTD. SENSIFIRM, EL GLOBAL TRADE LTD CEL100US01SNS sensiFirm - RevMed, El Global Trade SENSIFIRM OTC Home Use Device User Manual IPL Hair ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
El Global Trade Ltd
FDA Applicant
El Global Trade, Ltd.

Sources (1)

  • FDA 510(k) K170637 24 fields · synced Sep 19, 2026