510(k) Report

510(k) · Cleared

Cleared

Magnetic Resonance Therapy Device

K903675510(k) TraditionalCleared Jan 17, 1991157-day reviewClass II21 CFR 890.5290

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

Mrt, Inc. · ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

Cleared on Jan 17, 1991 after a 157-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided
Jan 17, 1991
Review
157 days
Class
Class II
Product code
ILX
Recalls
None
Predicates
0

11 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared1997: 1 descendant cleared2008: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2009: 2 descendants cleared2012: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK903675 Magnetic Resonance Therapy DeviceMrt, Inc. · 1991
  2. Descendant · cites it directly · 8 of its ownK070541 Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IIIvivi Technologies, Inc. · 2008
  3. Descendant · 2 generations on · 3 of its ownK092044 Orthocor Knee System, Median, Large, X-LargeOrthocor Medical · 2009
  4. Descendant · 2 generations on · 2 of its ownK091996 Orthocor Knee System BasicOrthocor Medical · 2009
  5. Descendant · 2 generations on · 1 of its ownK152432 ActiPatch (R)Bioelectronics Corporation · 2017
  6. Descendant · 3 generations on · 1 of its ownK121702 Orthocor Active Device Orthocor General Use Active DeviceOrthocor Medical · 2013

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1997: 12007: 12008: 12009: 22012: 12013: 12017: 12019: 12020: 12024: 1
1997high 2 (2009) · low 0 (1998)2026

Most influential descendants

Showing 5 of 11 · See all
  • K070541Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IIIvivi Technologies, Inc. · 2008 · cites it directly8descendants
  • K092044Orthocor Knee System, Median, Large, X-LargeOrthocor Medical · 2009 · 2 generations on3descendants
  • K091996Orthocor Knee System BasicOrthocor Medical · 2009 · 2 generations on2descendants
  • K152432ActiPatch (R)Bioelectronics Corporation · 2017 · 2 generations on1descendant
  • K121702Orthocor Active Device Orthocor General Use Active DeviceOrthocor Medical · 2013 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903675Magnetic Resonance Therapy DeviceMrt, Inc.1991—
+1K070541Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IIIvivi Technologies, Inc.2008—
+2K092044Orthocor Knee System, Median, Large, X-LargeOrthocor Medical2009—
+2K091996Orthocor Knee System BasicOrthocor Medical2009—
+2K152432ActiPatch (R)Bioelectronics Corporation2017—
+3K121702Orthocor Active Device Orthocor General Use Active DeviceOrthocor Medical2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200710
200810
200920
201210
201310
201710
201910
202010
202410
FIG. 1 — Lineage of K903675, 1991–2024Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ILX? 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 ILX device

  1. #1 K241395 Active System; Avenue8score 9.4 · 4 generations · no Class I recall
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K070541Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IIIvivi Technologies, Inc.20088
K070931Model PMT850Promedtek, Inc.20070
K972093Regenesis Model 42Regenesis Biomedical, Inc.19970

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, K070541 (Ivivi Technologies, Inc., 2008) has gone furthest, with 8 descendants of its own.

How does its category compare?

All ILX devices

ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ILX

1in 2024

2007: 12008: 12009: 22010: 12012: 12013: 22019: 12020: 12024: 1
2007high 2 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILX

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

Recalls per year · ILX

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · ILX

1in 2025

2007: 12008: 22009: 12011: 12016: 12023: 12025: 1
2007high 2 (2008) · low 0 (2010)2025

MAUDE reports naming product code ILX, 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—01
20081—12
20092—01
20101—00
20110—01
20121—00
20132—00
20140—00
20150—00
20160—01
20170—00
20180—00
20191—00
20201—00
20210—00
20220—00
20230—01
20241—00
20250—01
20260—0—
Cite this page

510(k) Report. “K903675: Magnetic Resonance Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K903675

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026