TBD TENS REUSABLE ELECTRODE— 510(k) K902195
Substantially EquivalentEmpi
FDA 510(k) clearance K902195 for TBD TENS REUSABLE ELECTRODE, Substantially Equivalent on 1990-06-08. Applicant: Empi. Device class: 2.
Clearance details
- Applicant
- Empi
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arden Hills, MN, US
Recent devices under product code GXY
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- K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
- K261522 — BioWave BioWraps
- K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
More clearances from Empi
view allRecalls naming K902195
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K902195.
Data sourced from openFDA. This site is unofficial and independent of the FDA.