Saalio
FDA 510(k) K191436 · Saalmann Medical GmbH & Co. KG
510(k) numberK191436
Submission
- Device name
- Saalio
- Applicant
- Saalmann Medical GmbH & Co. KG
Bad Oeynhausen, DE - Received
- May 30, 2019
- Decision date
- October 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EGJ – Device, Iontophoresis, Other Uses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5525
- Specialty
- Physical Medicine
Other 510(k)s with product code EGJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242041 | STOPWET iontophoresis apparatus (SW01)EGJ · Traditional | Taiwan Medical Electronics Co., Ltd. | 04/01/2025SE |
| 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 |
| 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 |
| K110636 | Tula Iontophoresis SystemEGJ · Traditional | Acclarent, Inc. | 06/16/2011SE |
Questions and answers
When was Saalio cleared by the FDA?
Saalio (K191436) received a 510(k) decision of Substantially Equivalent on October 18, 2019, 141 days after the submission was received.
What is the product code of K191436?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.