EMS 400
FDA 510(k) K022493 · Body Clock Health Care, Ltd.
510(k) numberK022493
Submission
- Device name
- EMS 400
- Applicant
- Body Clock Health Care, Ltd.
London, England, GB - Received
- July 29, 2002
- Decision date
- October 11, 2002
- 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
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 |
More from Sunmed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K091045 | Smart TENS, Model: D-BC05TGZJ · Traditional | 12/18/2009SE |
| K041359 | Body Clock Stimplus and Stimplus ProGZJ · Traditional | 08/20/2004SE |
| K022849 | Body Clock TENS N' ToneGZJ · Traditional | 05/20/2003SE |
| K021846 | 804SIII; 804W; Libra TENS; 410; S-Tens IIGZJ · Traditional | 11/22/2002SE |
| K022731 | V TENS PlusGZJ · Traditional | 11/14/2002SE |
| K022076 | First Choice & First Choice PlusGZJ · Traditional | 09/24/2002SE |
Questions and answers
When was EMS 400 cleared by the FDA?
EMS 400 (K022493) received a 510(k) decision of Substantially Equivalent on October 11, 2002, 74 days after the submission was received.
What is the product code of K022493?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.