510(k) · Cleared
ClearedT.E.a.R. TECH3
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 Nov 13, 2009 as substantially equivalent to K030507 (Vision Quest Industries, Inc., 2003) and 1 other predicate after a 259-day review. Its family tree reaches back 2 generations to 1993. 2 later devices descend from it.
- Decided
- Nov 13, 2009
- Review
- 259 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931781 (1993). 9 ancestors in all, the oldest K872976 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK931781 Jace Tri-Stim DeviceJace Systems, Inc. · 1993
- 1 generation backK030507 T.E.a.R. TECH3 Model #44TT03Vision Quest Industries, Inc. · 2003
- This deviceK090532 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931781 | Jace Tri-Stim Device | Jace Systems, Inc. | 1993 | — |
| −1 | K030507 | T.E.a.R. TECH3 Model #44TT03 | Vision Quest Industries, Inc. | 2003 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 19.7 · 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? (3)
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 |
|---|---|---|---|
| * | K030507 | T.E.a.R. TECH3 Model #44TT03Summary page 1…cturer Product Name 510(k) Number Vision Quest Industries, Inc. 18011 Mitchell South T.E.A.R. Tech3 K030507 Irvine, CA 92614 Staodyn, Inc. 1225 Florida AvenueTuaeK268 P.O0. Box 1379 Twv… | 2003 |
| * | K050046 | Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SSummary page 1…Twv 916 Longmont, Colorado 80502-1379 Compex Technologies, Inc. (formerly Staodyn) IF aeK050046 I8Il Old Highway 8 3Wv New Brighton, MN 55112 Device Description: The T.E.A.R. Tech 3 IF/Muscle St… | 2005 |
| * | — | Twv Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183692 | Avid IF2 | 2019 | 1 |
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 16 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K183692 (Vision Quest Industries Inc./Dba VQ Orthocare, 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K030507.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 intended for the following applications: The High Volt Pulsed Current Stimulation and Neuromuscular Electrical Stimulation can be used in the following applications: Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increases local blood circulation Muscle re-education Maintaining or increasing range of motion Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis…
Read the full statement (137 words)
The T.E.A.R. Tech3 IF/Muscle Stimulator is intended for the following applications:
The High Volt Pulsed Current Stimulation and Neuromuscular Electrical Stimulation can be used in the following applications:
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increases local blood circulation
Muscle re-education
Maintaining or increasing range of motion
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Interferential Stimulation can be used in the following applications:
Symptomatic relief of post traumatic acute pain
Symptomatic relief of chronic pain intractable pain
Relaxation of muscle spasms
Maintaining or increasing range of motion
Increases local blood circulation
Pulsed Direct Current stimulation can be used in the following applications:
Reduction of edema (under negative electrode)
Relaxation of muscle spasm
Increasing local blood circulation
Retardation or prevention of disuse atrophy
Muscle re-education
Maintaining or increasing of range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090532: T.E.a.R. TECH3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090532
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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