510(k) · Cleared

Cleared

Vital Stim

K023347510(k) TraditionalCleared Dec 6, 200260-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

Chattanooga Group · IPF Stimulator, Muscle, Powered

Cleared on Dec 6, 2002 after a 60-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.

Decided: Dec 6, 2002
Review: 60 days
Class: Class II
Product code: IPF
Recalls: None
Predicates: 0

11 later devices descend from it, 4 citing it directly.

This deviceK023347 Vital StimChattanooga Group · 2002
Descendant · cites it directly · 6 of its ownK070807 Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesPepin Mfg., Inc. · 2007
Descendant · 2 generations on · 4 of its ownK080386 Columbia 600 Electrode, Columbia 06 LeadwireColumbia Scientific Development, LLC · 2008
Descendant · cites it directly · 3 of its ownK083756 Guardian 150 ElectrodeSelectivemed Components, Inc. · 2009
Descendant · cites it directly · 2 of its ownK070425 Vitalstim ExperiaChattanooga Group · 2007
Descendant · 2 generations on · 1 of its ownK121483 Reusable Cutaneous ElectrodeAmpcare, LLC · 2012

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2007high 2 (2007) · low 0 (2010)2026

Most influential descendants

Showing 5 of 11 · See all

K070807Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesPepin Mfg., Inc. · 2007 · cites it directly6descendants
K080386Columbia 600 Electrode, Columbia 06 LeadwireColumbia Scientific Development, LLC · 2008 · 2 generations on4descendants
K083756Guardian 150 ElectrodeSelectivemed Components, Inc. · 2009 · cites it directly3descendants
K070425Vitalstim ExperiaChattanooga Group · 2007 · cites it directly2descendants
K121483Reusable Cutaneous ElectrodeAmpcare, LLC · 2012 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K023347	Vital Stim	Chattanooga Group	2002	—
+1	K070807	Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes	Pepin Mfg., Inc.	2007	—
+2	K080386	Columbia 600 Electrode, Columbia 06 Leadwire	Columbia Scientific Development, LLC	2008	—
+1	K083756	Guardian 150 Electrode	Selectivemed Components, Inc.	2009	—
+1	K070425	Vitalstim Experia	Chattanooga Group	2007	—
+2	K121483	Reusable Cutaneous Electrode	Ampcare, LLC	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2008	1	0
2009	1	0
2011	2	0
2012	1	0
2013	2	0
2016	1	0
2018	1	0

FIG. 1 — Lineage of K023347, 2002–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 K241433 EVE Synergy (EVE-20M)score 19.6 · 25 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (11)

See all 11

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K070807	Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes	Pepin Mfg., Inc.	2007	6
K083756	Guardian 150 Electrode	Selectivemed Components, Inc.	2009	3
K070425	Vitalstim Experia	Chattanooga Group	2007	2
K092202	Eswallow Dysphagia Therapy Kit, Pmi Dysphagia Therapy Kit	Eswallow USA	2011	0

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?

Of its descendants, K070807 (Pepin Mfg., Inc., 2007) has gone furthest, with 6 descendants of its own.

How does its category compare?

All IPF devices

IPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IPF

3in 2025

2007high 15 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IPF

257in 2025

2007high 275 (2011) · low 43 (2015)2026

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

Recalls per year · IPF

1in 2023

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	143	0	11
2008	6	140	1	213
2009	7	216	0	150
2010	4	121	0	14
2011	4	275	1	25
2012	4	269	3	16
2013	10	180	0	6
2014	4	264	0	19
2015	3	43	0	11
2016	7	113	0	8
2017	5	110	0	2
2018	5	73	0	3
2019	4	133	0	10
2020	9	121	0	13
2021	15	98	0	3
2022	7	108	0	4
2023	9	255	1	8
2024	7	201	0	5
2025	3	257	0	8
2026	3	206	0	—

What is it indicated for?

Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K023347 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023347: Vital Stim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023347

Report an extraction error

Are you the manufacturer?

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