FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
S21 OTC Transcutaneous Electrical Nerve Stimulator
K Number: K233095
·
Decision Mar 1, 2024
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
227
Applicant Total
8
Review Days
157
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Basic Information
- Device Name
- S21 OTC Transcutaneous Electrical Nerve Stimulator
- K Number
- K233095
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Micro Current Technology, Inc.
- Date Received
- September 26, 2023
- Decision Date
- March 1, 2024
- Product Code
- NUH
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | FDA class 2 | Neurology |
Similar 510(k) Clearances
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Other Clearances by Micro Current Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252218 | MF SC GEN2 Facial Toning System | Jul 18, 2025 | Substantially Equivalent |
| K233525 | MF SC Facial Toning System | Nov 24, 2023 | Substantially Equivalent |
| K183189 | Ultra OTC Facial Toning System | Apr 17, 2019 | Substantially Equivalent |
| K181062 | Ultra Facial Toning System | Jul 18, 2018 | Substantially Equivalent |
| K033253 | S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR | Oct 21, 2003 | Substantially Equivalent |
| K032653 | E275 | Sep 12, 2003 | Substantially Equivalent |
| K993823 | MED-4000 | Nov 19, 1999 | Substantially Equivalent |