510(k) · Cleared
ClearedT.E.a.R. TECH3 Model #44TT03
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision Quest Industries, Inc. · IPF Stimulator, Muscle, Powered
Cleared on May 20, 2003 as substantially equivalent to K982388 (Vision Quest Industries, Inc., 1998) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it.
- Decided
- May 20, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K931781 (1993). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931781 Jace Tri-Stim DeviceJace Systems, Inc. · 1993
- This deviceK030507 T.E.a.R. TECH3 Model #44TT03Vision Quest Industries, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK090532 T.E.a.R. TECH3Vision Quest Industries, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK183692 Avid IF2Vision Quest Industries Inc./Dba VQ Orthocare · 2019
- Descendant · 2 generations on · 0 of its ownK202490 Avid CT2Vision Quest Industries Inc./Dba VQ Orthocare · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931781 | Jace Tri-Stim Device | Jace Systems, Inc. | 1993 | — |
| 0 (this device) | K030507 | T.E.a.R. TECH3 Model #44TT03 | Vision Quest Industries, Inc. | 2003 | — |
| +1 | K090532 | T.E.a.R. TECH3 | Vision Quest Industries, Inc. | 2009 | — |
| +1 | K183692 | Avid IF2 | Vision Quest Industries Inc./Dba VQ Orthocare | 2019 | — |
| +2 | K202490 | Avid CT2 | Vision Quest Industries Inc./Dba VQ Orthocare | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
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 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
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 | Decided |
|---|---|---|---|
| * | K982388 | Surgi StimSummary page 1…nt Therapy (LIH) Stimulator, Muscle, Powered (IPF) Predicate Device Name: Surgi Stim 5 1O(k) Number: K982388 VisionQuest Industries, Inc., 18011 Mitchell South, Irvine, CA 92614… | 1998 |
| * | K931781 | Jace Tri-Stim DeviceSummary page 1…es, Inc., 18011 Mitchell South, Irvine, CA 92614 Jace Tri-Stim 5 1O(k) Number: K93 1781 Thera-Kinetics DBA Jace Systems 7 Camegie Plaza, Cherry Hill, NJ 0800… | 1993 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 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?
The T.E.A.R. Tech3 IF/Muscle Stimulator is a combination device and has the same indications for use as two different types of predicate devices. The High Volt Pulsed Current Stimulator and Neuromuscular Electrical Stimulators share the same indications for use as listed below: Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increases local blood circulation Promotes muscle re-education and range of motion Maintaining and…
Read the full statement (118 words)
The T.E.A.R. Tech3 IF/Muscle Stimulator is a combination device and has the same indications for use as two different types of predicate devices.
The High Volt Pulsed Current Stimulator and Neuromuscular Electrical Stimulators share the same indications for use as listed below:
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increases local blood circulation
Promotes muscle re-education and range of motion
Maintaining and increasing range of motion
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Interferential Stimulators have one additional indication for use:
Provides symptomatic relief and management of post surgical, acute, or chronic pain
The target population for this device are patients with chronic, acute pain syndrome, and/or recovering from orthopedic related surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030507: T.E.a.R. TECH3 Model #44TT03.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030507
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