S21 Transcutaneous Electrical Nerve Stimulator
FDA 510(k) K033253 · Micro Current Technology, Inc.
510(k) numberK033253
Submission
- Device name
- S21 Transcutaneous Electrical Nerve Stimulator
- Applicant
- Micro Current Technology, Inc.
Seattle, WA, US - Received
- October 8, 2003
- Decision date
- October 21, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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| K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)GZJ · Traditional | Bozhou Rongjian Medical Appliance Co., Ltd. | 05/25/2022SE |
More from Bozhou Rongjian Medical Appliance Co., Ltd.
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| K252218 | MF SC GEN2 Facial Toning SystemNFO · Special | 07/18/2025SE |
| K233095 | S21 OTC Transcutaneous Electrical Nerve StimulatorNUH · Traditional | 03/01/2024SE |
| K233525 | MF SC Facial Toning SystemNFO · Traditional | 11/24/2023SE |
| K183189 | Ultra OTC Facial Toning SystemNFO · Traditional | 04/17/2019SE |
| K181062 | Ultra Facial Toning SystemNFO · Traditional | 07/18/2018SE |
| K032653 | E275GZJ · Traditional | 09/12/2003SE |
| K993823 | MED-4000GZJ · Traditional | 11/19/1999SE |
Questions and answers
When was S21 Transcutaneous Electrical Nerve Stimulator cleared by the FDA?
S21 Transcutaneous Electrical Nerve Stimulator (K033253) received a 510(k) decision of Substantially Equivalent on October 21, 2003, 13 days after the submission was received.
What is the product code of K033253?
The FDA product code is GZJ – Stimulator, Nerve, Transcutaneous, For Pain Relief, a Class II (moderate risk) device regulated under 21 CFR 882.5890.