T.E.A.R. TECH3 Model #44TT03
FDA 510(k) K030507 · Vision Quest Industries, Inc.
510(k) numberK030507
Submission
- Device name
- T.E.A.R. TECH3 Model #44TT03
- Applicant
- Vision Quest Industries, Inc.
Irvine, CA, US - Received
- February 19, 2003
- Decision date
- May 20, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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| K241488 | TrainFES AdvanceIPF · Traditional | Trainfes | 02/05/2025SE |
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| K240992 | eMVFit (MVF-10M)IPF · Traditional | Weero Co., Ltd. | 10/10/2024SE |
| K240234 | BTL-899MSIPF · Traditional | BTL Industries, Inc. | 08/17/2024SE |
| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | Sunmed, LLC | 08/02/2024SE |
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Questions and answers
When was T.E.A.R. TECH3 Model #44TT03 cleared by the FDA?
T.E.A.R. TECH3 Model #44TT03 (K030507) received a 510(k) decision of Substantially Equivalent on May 20, 2003, 90 days after the submission was received.
What is the product code of K030507?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.