510(k) · Cleared

Cleared

KFH Energy, Model: E1

K073008510(k) TraditionalCleared Mar 11, 2008139-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

Kingfisher Healthcare NV · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Mar 11, 2008 as substantially equivalent to K896948 (Electromedical Products, Inc., 1990) and 8 other predicates after a 139-day review. Its family tree reaches back 2 generations to 2001.

Decided: Mar 11, 2008
Review: 139 days
Class: Class II
Product code: GZJ
Recalls: None
Predicates: 9

Its longest line of descent runs back 2 generations to K002874 (2001). 10 ancestors in all, the oldest K831144 (1983). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002874 Well-TensWell-Life Consultant · 2001
1 generation backK050435 E-Stim IILhasa Oms, Inc. · 2005
This deviceK073008 KFH Energy, Model: E1Kingfisher Healthcare NV · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002874	Well-Tens	Well-Life Consultant	2001	—
−1	K050435	E-Stim II	Lhasa Oms, Inc.	2005	—
0 (this device)	K073008	KFH Energy, Model: E1	Kingfisher Healthcare NV	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	2	0
1988	1	0
1990	1	0
1991	1	0
1992	2	0
2000	1	0

FIG. 1 — Lineage of K073008, 2001–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GZJ? 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 GZJ device

#1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (9)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K896948	Alpha-Stim CS Summary page 2 …lthcare NV KFH Energy model El is substantially equivalent in design, use and materials to the: Electromedical Products Intl Inc, Alpha Stim K896948, K881753, K831145, K831144 BioMedical Life Systems, Electro-nerve stimulator TENS model micro plus-A…	Electromedical Products, Inc.	1990	—
*	K881753	Alpha-Stim 350 Summary page 2 …V KFH Energy model El is substantially equivalent in design, use and materials to the: Electromedical Products Intl Inc, Alpha Stim K896948, K881753, K831145, K831144 BioMedical Life Systems, Electro-nerve stimulator TENS model micro plus-A K915210…	Electromedical Products, Inc.	1988	—
*	K831145	Alpha-Stim 350 Summary page 2 …rgy model El is substantially equivalent in design, use and materials to the: Electromedical Products Intl Inc, Alpha Stim K896948, K881753, K831145, K831144 BioMedical Life Systems, Electro-nerve stimulator TENS model micro plus-A K915210 Lhasa O…	Electromedical Products, Inc.	1983	—
*	K831144	Alpha-Stim 2000 Summary page 2 …El is substantially equivalent in design, use and materials to the: Electromedical Products Intl Inc, Alpha Stim K896948, K881753, K831145, K831144 BioMedical Life Systems, Electro-nerve stimulator TENS model micro plus-A K915210 Lhasa Oris Inc,…	Electromedical Products, Inc.	1983	—
*	K915210	Electro-Nerve Stimulator Tens Model Micro Plus-a Summary page 2 …ha Stim K896948, K881753, K831145, K831144 BioMedical Life Systems, Electro-nerve stimulator TENS model micro plus-A K915210 Lhasa Oris Inc, E Stim II K050435 Fuji Dynamics Ltd, Medisana Digital Tens…	Biomedical Life Systems, Inc.	1992	—
*	K050435	E-Stim II Summary page 2 …31144 BioMedical Life Systems, Electro-nerve stimulator TENS model micro plus-A K915210 Lhasa Oris Inc, E Stim II K050435 Fuji Dynamics Ltd, Medisana Digital Tens K994265 Globalcare Intl., Inc, Globalcare Micro II and Mi…	Lhasa Oms, Inc.	2005	—
*	K994265	Medisana Digital Tens Summary page 2 …lus-A K915210 Lhasa Oris Inc, E Stim II K050435 Fuji Dynamics Ltd, Medisana Digital Tens K994265 Globalcare Intl., Inc, Globalcare Micro II and Microcare (TENS) K903394 510(k) Summary Section I…	Fuji Dynamics Limited	2000	—
*	K903394	Globalcare Micro 11 and Microcare (Tens) Summary page 2 …Fuji Dynamics Ltd, Medisana Digital Tens K994265 Globalcare Intl., Inc, Globalcare Micro II and Microcare (TENS) K903394 510(k) Summary Section I Page 3 of 6 25-Feb-08 K073008…	Globalcare Intl., Inc.	1991	—
*	K923298	Micro 100,200,300, & 400 Tens Summary page 3 …K KFH Response to Email of S. Hinckley 7 Feb 2008 Skylark Device Co Ltd, Micro 300 K923298 Comparison of Technological Characteristics The Kingfisher Healthcare NV KFH Energy model El is a microcurrent TENS device fo…	Skylark Device Co., Ltd.	1992	—

Also cleared against K896948: 1 other device →

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 7 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
None of the 10 ancestors has a recall.
1 other device also cites its predicate K896948.

How does its category compare?

All GZJ devices

GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · GZJ

1in 2025

2007high 16 (2009) · low 1 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZJ

207in 2024

2007high 344 (2014) · low 113 (2017)2026

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

Recalls per year · GZJ

1in 2011

2007high 4 (2007) · low 0 (2009)2026

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

Adverse event reports per year · GZJ

13in 2025

2007high 58 (2017) · low 4 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	13	223	4	4
2008	11	136	1	45
2009	16	155	0	17
2010	5	232	0	22
2011	5	168	1	22
2012	12	154	0	20
2013	2	—	0	10
2014	4	344	0	23
2015	3	202	0	18
2016	3	163	0	32
2017	3	113	0	58
2018	2	—	0	21
2019	3	156	0	7
2020	4	183	0	10
2021	3	231	0	5
2022	4	175	0	4
2023	1	—	0	39
2024	3	207	0	12
2025	1	—	0	13
2026	2	—	0	—

What is it indicated for?

The KFH Energy device is indicated for the symptomatic relief of:

Chronic Intractable Pain

Post-Traumatic Pain

Post-Surgical Pain

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073008 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073008: KFH Energy, Model: E1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073008

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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