# K030507: T.E.a.R. TECH3 Model #44TT03

- Pathway: 510(k) (Traditional)
- Applicant: Vision Quest Industries, Inc.
- Decided: May 20, 2003 after 90 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931781 (1993). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982388: Surgi Stim, Vision Quest Industries, Inc. (1998) Summary page 1.
- K931781: Jace Tri-Stim Device, Jace Systems, Inc. (1993) Summary page 1.

## Most influential descendants
- K090532: T.E.a.R. TECH3 (2009), 2 descendants of its own
- K183692: Avid IF2 (2019), 1 descendant of its own
- K202490: Avid CT2 (2020), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K030507
Methodology: https://510kreport.com/methodology