EMS 8100
FDA 510(k) K895301 · Henley Intl.
510(k) numberK895301
Submission
- Device name
- EMS 8100
- Applicant
- Henley Intl.
Sugar Land, TX, US - Received
- August 25, 1989
- Decision date
- February 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| 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 |
More from Sunmed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K943449 | Neurological Diagnostic DevicesGXY · Traditional | 11/15/1995SE |
| K926279 | Upper Body ExerciserISD · Traditional | 05/05/1994SE |
| K926278 | Stair ClimberISD · Traditional | 05/05/1994SE |
| K926287 | Exercise BicycleISD · Traditional | 03/22/1994SE |
| K926314 | Hydra Fitness Model 311 Total PowerISD · Traditional | 03/18/1994SE |
| K926313 | Computerized Testing and Exercise SystemsBXB · Traditional | 02/04/1994SE |
| K915864 | Monotrode Cutaneous ElectrodeGXY · Traditional | 07/21/1993SE |
| K922036 | Sonopuls 591IMG · Traditional | 06/29/1993SE |
| K926316 | True-Trac, StratusJFB · Traditional | 03/24/1993SE |
| K920983 | Sonopuls 590IMI · Traditional | 03/09/1993SE |
Questions and answers
When was EMS 8100 cleared by the FDA?
EMS 8100 (K895301) received a 510(k) decision of Substantially Equivalent on February 20, 1990, 179 days after the submission was received.
What is the product code of K895301?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.