Skintact
FDA 510(k) K140340 · Leonhard Lang GmbH
510(k) numberK140340
Submission
- Device name
- Skintact
- Applicant
- Leonhard Lang GmbH
Stillwater, MN, US - Received
- February 11, 2014
- Decision date
- May 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)GXY · Traditional | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 05/08/2026SE |
| K254183 | MR Conditional Cup ElectrodesGXY · Traditional | Technomed Europe | 05/07/2026SE |
| K252439 | Tutamen Self Adhesive ElectrodesGXY · Traditional | Dongguan Tutamen Metalwork Co., Ltd. | 05/01/2026SE |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial…GXY · Traditional | Otto Bock Healthcare Products GmbH | 04/22/2026SE |
| K260363 | Ceribell Brain Monitor HeadbandGXY · Abbreviated | Ceribell, Inc. | 04/03/2026SE |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)GXY · Special | Bionit Labs Srl | 03/12/2026SE |
More from Bionit Labs Srl
| 510(k) | Device | Decision |
|---|---|---|
| K142803 | Skintact, various other tradenamesMKJ · Traditional | 12/02/2014SE |
| K140500 | SkintactGEI · Traditional | 07/29/2014SE |
| K103186 | Skintact Radiotransparent Multifunction ElectrodesMKJ · Traditional | 02/08/2011SE |
| K092291 | Skintact and Various Other TradenamesDRX · Special | 08/21/2009SE |
| K081371 | Skintact Pediatric Multifunction Electrodes with DH03 GelMKJ · Traditional | 09/24/2008SE |
| K080106 | Skintact Pre-Wired ECG Electrodes with Conductive AdhesiveDRX · Special | 02/01/2008SE |
| K073104 | Skintact and Various Other TradenamesDRX · Special | 11/16/2007SE |
| K072233 | Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible…MKJ · Special | 10/05/2007SE |
| K063161 | Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelGEI · Special | 11/21/2006SE |
| K041883 | Skintact Multifunction Electrodes, Model DF 21MKJ · Traditional | 09/07/2004SE |
Questions and answers
When was Skintact cleared by the FDA?
Skintact (K140340) received a 510(k) decision of Substantially Equivalent on May 21, 2014, 99 days after the submission was received.
What is the product code of K140340?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.