Shear Stress Therapeutics SST 3000
FDA 510(k) K182163 · Shear Stress Therapeutics, LLC
510(k) numberK182163
Submission
- Device name
- Shear Stress Therapeutics SST 3000
- Applicant
- Shear Stress Therapeutics, LLC
Tulsa, OK, US - Received
- August 10, 2018
- Decision date
- July 9, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code IPF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M)IPF · Traditional | Weero Co., Ltd. | 06/08/2026SE |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
| K260142 | StimelMD (SSMD) systemIPF · Special | Motion Informatics ltd. | 05/27/2026SE |
| K251083 | Compact IIIPF · Traditional | Enraf-Nonius, B.V. | 09/12/2025SE |
| K241433 | EVE Synergy (EVE-20M)IPF · Traditional | Weero Co., Ltd. | 06/04/2025SE |
| K241488 | TrainFES AdvanceIPF · Traditional | Trainfes | 02/05/2025SE |
| K240348 | Quantum Mitohormesis (QMT) (M2101)IPF · Abbreviated | Quantumtx Pte. , Ltd. | 12/19/2024SE |
| 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 |
Questions and answers
When was Shear Stress Therapeutics SST 3000 cleared by the FDA?
Shear Stress Therapeutics SST 3000 (K182163) received a 510(k) decision of Substantially Equivalent on July 9, 2019, 333 days after the submission was received.
What is the product code of K182163?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.