510(k) Report

510(k) · Cleared

Cleared

Everlife Powered Muscle Stimulator, Model E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311

K071320510(k) TraditionalCleared Aug 17, 200799-day reviewClass II21 CFR 890.5850

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. · IPF Stimulator, Muscle, Powered

Cleared on Aug 17, 2007 as substantially equivalent to K002336 (Apex Medical Corp., 2001) and 2 other predicates after a 99-day review. Its family tree reaches back 1 generation to 2001.

Decided
Aug 17, 2007
Review
99 days
Class
Class II
Product code
IPF
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K002336 (2001). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2001: 1 other ancestorK002336 · MS104A, Newmini II (Ems-II), Model AP-101050T and Medtrim (Ems-V), Model AP-102050T · Apex Medical Corp. · 200120002002200420062008
Other ancestors, by generation 1 generation back: 2 other ancestors K002336 · MS104A, Newmini II (Ems-II), Model AP-101050T and Medtrim (Ems-V), Model AP-102050T · Apex Medical Corp. · 20010
  1. Root · 1 generation backK002336 MS104A, Newmini II (Ems-II), Model AP-101050T and Medtrim (Ems-V)…Apex Medical Corp. · 2001
  2. This deviceK071320 Everlife Powered Muscle Stimulator, Model E-100204, E-100504…Everlife Medical Equipment Co., Ltd. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002336MS104A, Newmini II (Ems-II), Model AP-101050T and Medtrim (Ems-V), Model…Apex Medical Corp.2001—
0 (this device)K071320Everlife Powered Muscle Stimulator, Model E-100204, E-100504, E-100509…Everlife Medical Equipment Co., Ltd.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
FIG. 1 — Lineage of K071320, 2001–2007Source: 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 IPF? 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 IPF device

  1. #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (3)

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
*K002336MS104A, Newmini II (Ems-II), Model AP-101050T and Medtrim (Ems-V), Model AP-102050T
Summary page 1
…TION Powered Muscle Stimulator NAME: REGULATION 890.5850, Class II NUMBER: PREDICATED APEX Powered Muscle Stimulator, DEVICE: K002336: MS-104A; K002339: AEMSV; K021754: TS-1311, TS-1312 1/2 I…
Apex Medical Corp.2001—
*K002339Aems V, Ems-1000, Model TS-140500 and Aems VI, Ems-1000 Plus, Model TS-140600
Summary page 1
…uscle Stimulator NAME: REGULATION 890.5850, Class II NUMBER: PREDICATED APEX Powered Muscle Stimulator, DEVICE: K002336: MS-104A; K002339: AEMSV; K021754: TS-1311, TS-1312 1/2 INTENDED USE:…
Apex Medical Corp.2001—
*K021754Apex Medical Digital Ems TS1311, TS1312
Summary page 1
…890.5850, Class II NUMBER: PREDICATED APEX Powered Muscle Stimulator, DEVICE: K002336: MS-104A; K002339: AEMSV; K021754: TS-1311, TS-1312 1/2 INTENDED USE: · Relaxation of muscle spasm…
Apex Medical Corp.2002—

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?

  • None of the 3 ancestors has a recall.

How does its category compare?

All IPF devices

IPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · IPF

3in 2025

2007: 82008: 62009: 72010: 42011: 42012: 42013: 102014: 42015: 32016: 72017: 52018: 52019: 42020: 92021: 152022: 72023: 92024: 72025: 32026 (partial year): 3
2007high 15 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IPF

257in 2025

2007: 143 days median2008: 140 days median2009: 216 days median2010: 121 days median2011: 275 days median2012: 269 days median2013: 180 days median2014: 264 days median2015: 43 days median2016: 113 days median2017: 110 days median2018: 73 days median2019: 133 days median2020: 121 days median2021: 98 days median2022: 108 days median2023: 255 days median2024: 201 days median2025: 257 days median2026 (partial year): 206 days median
2007high 275 (2011) · low 43 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IPF

1in 2023

2008: 12011: 12012: 32023: 1
2007high 3 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IPF

8in 2025

2007: 112008: 2132009: 1502010: 142011: 252012: 162013: 62014: 192015: 112016: 82017: 22018: 32019: 102020: 132021: 32022: 42023: 82024: 52025: 8
2007high 213 (2008) · low 2 (2017)2025

MAUDE reports naming product code IPF, 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
20078143011
200861401213
200972160150
20104121014
20114275125
20124269316
20131018006
20144264019
2015343011
2016711308
2017511002
201857303
20194133010
20209121013
2021159803
2022710804
2023925518
2024720105
2025325708
202632060—

What is it indicated for?

used to apply an electrical current to electrodes on patient's skin to function as:

Relaxation of muscle spasms

Prevention or retardation of disuse atrophy

Muscle re-education

Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Maintaining or increasing range of motion

Indications for use as stated in the FDA summary.

More from Everlife Medical Equipment Co., Ltd.

3 FDA decisions under this applicant name. See the company

  • K071624Everelife Transcutaneous Muscle StimulatorEverlife Medical Equipment Co., Ltd. · 2007
  • K070890Everlife Interferential Current Therapy, Model IF-100507Everlife Medical Equipment Co., Ltd. · 2007

Recent decisions in IPF

The IPF category page

  • K253542Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
  • K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali Nezakati · 2026
  • K260142StimelMD (SSMD) systemMotion Informatics ltd. · 2026
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  • K241433EVE Synergy (EVE-20M)Weero Co., Ltd. · 2025

https://510kreport.com/device/K071320 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071320: Everlife Powered Muscle Stimulator, Model E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071320

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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