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510(k) K061269

XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES by Excel Tech. , Ltd. — Product Code GXY

K061269 is an FDA 510(k) premarket notification submitted by Excel Tech. , Ltd. for the device "XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES". The FDA issued a decision of Substantially Equivalent on August 14, 2006. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Excel Tech. , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2006
Date Received
May 5, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

Other clearances by Excel Tech. , Ltd.

  • K062549 — XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 10523 (October 4, 2006)
  • K053386 — XLTEK EMU40 EEG HEADBOX, MODEL PK1072 (April 21, 2006)
  • K053058 — XLTEK NEUROPATH, MODEL PK1070 (February 7, 2006)
  • K052112 — XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 (October 28, 2005)
  • K052111 — XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 (August 17, 2005)
  • K042223 — XLTEK CONNEX IP HEADBOX, MODEL 1054 (September 16, 2004)
  • K042150 — XLTEK TREX MODEL#10309 (August 27, 2004)
  • K040358 — XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 (August 6, 2004)
  • K040360 — EMU128S, MODEL EX-NW-128S (March 12, 2004)
  • K022037 — XLTEK SLEEP SYSTEM (September 10, 2002)

Other clearances for product code GXY

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  • K261442 — Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electr (June 26, 2026)
  • K261522 — BioWave BioWraps (June 3, 2026)
  • K253237 — Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) (May 8, 2026)
  • K254183 — MR Conditional Cup Electrodes (May 7, 2026)
  • K252439 — Tutamen Self Adhesive Electrodes (May 1, 2026)
  • K253256 — myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart (April 22, 2026)
  • K260363 — Ceribell Brain Monitor Headband (April 3, 2026)
  • K260453 — Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (March 12, 2026)
  • K254033 — Ceribell Instant EEG Headset (February 9, 2026)

FDA data resources