Digitimer DS7AP Constant Current Stimulator
FDA 510(k) K172381 · Digitimer , Ltd.
510(k) numberK172381
Submission
- Device name
- Digitimer DS7AP Constant Current Stimulator
- Applicant
- Digitimer , Ltd.
Welwyn Garden City, GB - Received
- August 7, 2017
- Decision date
- March 6, 2018
- 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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| 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 |
|---|---|---|
| K051357 | DS7A Constant Current High Voltage Stimulator, Model DS7A; DS7AH Constant Current High…GWF · Traditional | 09/20/2005SE |
Questions and answers
When was Digitimer DS7AP Constant Current Stimulator cleared by the FDA?
Digitimer DS7AP Constant Current Stimulator (K172381) received a 510(k) decision of Substantially Equivalent on March 6, 2018, 211 days after the submission was received.
What is the product code of K172381?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.