Model 6110 Iontophoretic Applicator
FDA 510(k) K863166 · Life-Tech Intl., Inc.
510(k) numberK863166
Submission
- Device name
- Model 6110 Iontophoretic Applicator
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- August 18, 1986
- Decision date
- March 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EGJ – Device, Iontophoresis, Other Uses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5525
- Specialty
- Physical Medicine
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|---|---|---|---|
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| K241267 | Hidroxa SE30EGJ · Traditional | Hidroxa Medical AB | 10/17/2024SE |
| K232020 | Iontophoresis ElectrodesEGJ · Traditional | Top-Rank Health Care Co., Ltd. | 10/16/2023SE |
| K192749 | DermadryEGJ · Traditional | Dermadry Laboratories, Inc. | 02/10/2020SE |
| K191436 | SaalioEGJ · Traditional | Saalmann Medical GmbH & Co. KG | 10/18/2019SE |
| K170835 | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEEGJ · Traditional | Hightech Development | 06/15/2018SE |
| K170291 | IontoDCEGJ · Traditional | Soterix Medical, Inc. | 05/01/2017SE |
| K150453 | TULA Iontophoresis System with EarsetEGJ · Special | Acclarent, Inc. | 05/20/2015SE |
| K133033 | Hidrex PSP1000EGJ · Traditional | Hidrex GmbH | 04/08/2015SE |
| K132832 | Activapatch Et Iontophoresis PatchEGJ · Traditional | Activatek, Inc. | 02/13/2014SE |
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| K954315 | PVC Abdominal/Rectal Pressure CatheterFEN · Traditional | 11/30/1995SE |
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| K953353 | Urovision JanusFEN · Traditional | 09/08/1995SE |
| K946108 | Ear-A-GatorKHH · Traditional | 06/13/1995SE |
| K913601 | MicrophorEGJ · Traditional | 07/15/1994SE |
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Questions and answers
When was Model 6110 Iontophoretic Applicator cleared by the FDA?
Model 6110 Iontophoretic Applicator (K863166) received a 510(k) decision of Substantially Equivalent on March 4, 1987, 198 days after the submission was received.
What is the product code of K863166?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.