Subderm TM
FDA 510(k) K853635 · General Medical Co.
510(k) numberK853635
Submission
- Device name
- Subderm TM
- Applicant
- General Medical Co.
Washington, DC, US - Received
- August 30, 1985
- Decision date
- December 20, 1985
- 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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| 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 |
| 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 |
More from Activatek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K926269 | Procedure KitLRO · Traditional | 08/27/1993SEKD |
| K912975 | Operand Lubricating JellyKMJ · Traditional | 09/27/1991SE |
| K912132 | Operand Lubricating JellyFHX · Traditional | 08/07/1991SE |
| K903669 | Genesis Insufflating CatheterBSY · Traditional | 09/12/1990SE |
| K900110 | Operand* Lubricating JellyKMJ · Traditional | 05/02/1990SE |
| K844652 | C.A.S.E. ContainerFSM · Traditional | 12/12/1984SE |
| K831320 | DrionicEGJ · Traditional | 07/19/1983SE |
| K820689 | C.S.R. WrappersFRG · Traditional | 04/09/1982SE |
| K820521 | Sterilization WrapFRG · Traditional | 03/18/1982SE |
| K802231 | Air Viva IIBTM · Traditional | 10/10/1980SE |
Questions and answers
When was Subderm TM cleared by the FDA?
Subderm TM (K853635) received a 510(k) decision of Substantially Equivalent on December 20, 1985, 112 days after the submission was received.
What is the product code of K853635?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.