Wireless TENS/EMS, Bruno, Aela— 510(k) K220997
Substantially EquivalentZmi Elecronics , Ltd.
FDA 510(k) clearance K220997 for Wireless TENS/EMS, Bruno, Aela, Substantially Equivalent on 2022-09-01. Applicant: Zmi Elecronics , Ltd.. Device class: 2.
Clearance details
- Applicant
- Zmi Elecronics , 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
- Traditional
- Location
- Kaohsiung, TW
Recent devices under product code NUH
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- K260425 — TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
- K253896 — TENS/EMS device (GUSE01)
- K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
Data sourced from openFDA. This site is unofficial and independent of the FDA.