510(k) · Cleared

Cleared

Sonic-Stim

K063135510(k) TraditionalCleared Feb 5, 2007112-day reviewClass II21 CFR 890.5860

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

Naimco, Inc. · IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Cleared on Feb 5, 2007 as substantially equivalent to K031077 (Chattanooga Group, 2003) and 1 other predicate after a 112-day review. Its family tree reaches back 1 generation to 2001.

Decided: Feb 5, 2007
Review: 112 days
Class: Class II
Product code: IMG
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K010749 (2001). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK010749 Electro Neuromuscular Stimulator, Model NMS-DigitalBiomedical Life Systems, Inc. · 2001
This deviceK063135 Sonic-StimNaimco, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010749	Electro Neuromuscular Stimulator, Model NMS-Digital	Biomedical Life Systems, Inc.	2001	—
0 (this device)	K063135	Sonic-Stim	Naimco, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K063135, 2001–2007Source: 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 IMG? 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 IMG device

#1 K244041 Ultrasound Therapy Workstation (XMS-UET2)score 10.7 · 3 generations · no Class I recall

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What was it cleared against? (2)

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
*	K031077	Vectra Epr System and Intelect Epr System Summary page 1 …ator Classification Name: Ultrasound and Powered Muscle Stimulator (per 21 CFR 890.5860 and 21 CFR 882.5890) Predicate Device: K031077 (Chattanooga Group Vectra GENiSYS) K01 0749 (Biomedical Life Science, QUADSTAR II) Description of Dev…	Chattanooga Group	2003	17
*	K010749	Electro Neuromuscular Stimulator, Model NMS-Digital Summary page 1 …or (per 21 CFR 890.5860 and 21 CFR 882.5890) Predicate Device: K031077 (Chattanooga Group Vectra GENiSYS) K01 0749 (Biomedical Life Science, QUADSTAR II) Description of Device: Ultrasound and Muscle Stimulator. Transcutaneous electrical…	Biomedical Life Systems, Inc.	2001	—

Also cleared against K031077: 8 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?

1 of the 2 ancestors has a recall of any class.
8 other devices also cite its predicate K031077.

How does its category compare?

All IMG devices

IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · IMG

1in 2025

2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IMG

226in 2011

2007high 226 (2011) · low 110 (2007)2026

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

Recalls per year · IMG

2in 2008

2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · IMG

9in 2025

2007high 37 (2008) · low 0 (2007)2025

MAUDE reports naming product code IMG, 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	3	110	0	0
2008	0	—	2	37
2009	0	—	0	26
2010	1	—	0	6
2011	3	226	0	21
2012	2	—	0	6
2013	0	—	0	4
2014	0	—	0	3
2015	2	—	0	4
2016	1	—	0	7
2017	0	—	0	3
2018	0	—	0	0
2019	0	—	0	14
2020	0	—	0	10
2021	0	—	0	13
2022	0	—	0	14
2023	0	—	0	7
2024	0	—	0	5
2025	1	—	0	9
2026	0	—	0	—

What is it indicated for?

For Russian, and High Volt * Relaxation of muscle spasms * Prevention or retardation of disuse atrophy * Increase local blood circulation * Muscle re-education * Maintaining or increasing range of motion * Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis For interferential and premodulated interferential * Symptomatic relief of chronic, intractable pain * Management of pain associated with post-traumatic or post-operative…

Read the full statement (123 words)

For Russian, and High Volt

* Relaxation of muscle spasms

* Prevention or retardation of disuse atrophy

* Increase local blood circulation

* Muscle re-education

* Maintaining or increasing range of motion

* Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For interferential and premodulated interferential

* Symptomatic relief of chronic, intractable pain

* Management of pain associated with post-traumatic or post-operative conditions

For Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

* Pain Relief

* Reduction of muscle spasms

* Joint contractures

For TENS and EMS

* Symptomatic relief and management of chronic intractable pain

* Adjunctive treatment in the management of post surgical and post traumatic acute pain condition

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063135 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063135: Sonic-Stim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063135

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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