AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)— 510(k) K222867
Substantially EquivalentAndon Health Co, Ltd.
FDA 510(k) clearance K222867 for AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS), Substantially Equivalent on 2022-12-21. Applicant: Andon Health Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Andon Health Co, Ltd.
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Tianjin, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.