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sensiFirm

by El Global Trade Ltd

510(k) K170637

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170637 Date14 Jul 2017ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PBX
FDA applicant
El Global Trade, Ltd.
Device class
Class II
Regulation
21 CFR Part 878.4400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K170637

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K170637
UDI-DISize and differences
Sensifirm - bronze CEL100US04SNS
EL GLOBAL TRADE LTD
CEL100US04SNS05060445341309 —On the market
sensiFirm CEL100US01SNS
EL GLOBAL TRADE LTD
CEL100US01SNS05060445341118 —On the market

Similar devices

Other devices filed under FDA product code PBX (Massager, Vacuum, Radio Frequency Induced Heat).

Other devices from El Global Trade Ltd.

See all devices from El Global Trade Ltd. →