510(k) Report

510(k) · Cleared

Cleared

Everlife Interferential Current Therapy, Model IF-100507

K070890510(k) TraditionalCleared Jun 29, 200791-day reviewClass II21 CFR 882.5890

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Everlife Medical Equipment Co., Ltd. · LIH Interferential Current Therapy

Cleared on Jun 29, 2007 as substantially equivalent to K952683 (Wholesale Medical Imports, Inc., 1997) after a 91-day review. Its family tree reaches back 2 generations to 1992.

Decided
Jun 29, 2007
Review
91 days
Class
Class II
Product code
LIH
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K921441 (1992). No later device cites it as a predicate yet.

  1. Root · 2 generations backK921441 Interferential Stimulator Model Inf 4150/aBiomedical Life Systems, Inc. · 1992
  2. 1 generation backK952683 Apex Medical Corp. Portable Interferential Stimulation DeviceWholesale Medical Imports, Inc. · 1997
  3. This deviceK070890 Everlife Interferential Current Therapy, Model IF-100507Everlife Medical Equipment Co., Ltd. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K921441Interferential Stimulator Model Inf 4150/aBiomedical Life Systems, Inc.1992—
−1K952683Apex Medical Corp. Portable Interferential Stimulation DeviceWholesale Medical Imports, Inc.1997—
0 (this device)K070890Everlife Interferential Current Therapy, Model IF-100507Everlife Medical Equipment Co., Ltd.2007—
FIG. 1 — Lineage of K070890, 1992–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LIH device

  1. #1 K231575 Vecttor VT-300score 7.1 · 2 generations · no Class I recall
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K952683Apex Medical Corp. Portable Interferential Stimulation Device
Summary page 1
…rent Therapy NAME: REGULATION Pre-Amendment NUMBER: PREDICATED APEX Interferential Current Therapy, IF-4000, DEVICE: K952683 INTENDED USE: The device is an interferential stimulator with TENS indications used for symptomatic re…
Wholesale Medical Imports, Inc.1997—

Also cleared against K952683: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
  • None of the 2 ancestors has a recall.
  • 6 other devices also cite its predicate K952683.

How does its category compare?

All LIH devices

LIH Interferential Current Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · LIH

1in 2024

2007: 12009: 22010: 22011: 12012: 22019: 12021: 12024: 1
2007high 2 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIH

Too few LIH 510(k)s in any year since 2007 to give a median.

Recalls per year · LIH

No recall names LIH since 2007.

Adverse event reports per year · LIH

1in 2025

2008: 142009: 32010: 22011: 12012: 12013: 12015: 12016: 12017: 12019: 12021: 12024: 12025: 1
2007high 14 (2008) · low 0 (2007)2025

MAUDE reports naming product code LIH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—014
20092—03
20102—02
20111—01
20122—01
20130—01
20140—00
20150—01
20160—01
20170—01
20180—00
20191—01
20200—00
20211—01
20220—00
20230—00
20241—01
20250—01
20260—0—

What is it indicated for?

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgicalandpost-traumaticacute pain.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K070890: Everlife Interferential Current Therapy, Model IF-100507.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070890

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026