ActiPatch(R)
FDA 510(k) K152432 · Bioelectronics Corporation
510(k) numberK152432
Submission
- Device name
- ActiPatch(R)
- Applicant
- Bioelectronics Corporation
Frederick, MD, US - Received
- August 27, 2015
- Decision date
- February 3, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PQY – Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5290
- Specialty
- Physical Medicine
Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.
Other 510(k)s with product code PQY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192234 | ActiPatchPQY · Traditional | Bioelectronics Corporation | 01/31/2020SE |
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Questions and answers
When was ActiPatch(R) cleared by the FDA?
ActiPatch(R) (K152432) received a 510(k) decision of Substantially Equivalent on February 3, 2017, 526 days after the submission was received.
What is the product code of K152432?
The FDA product code is PQY – Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain, a Class II (moderate risk) device regulated under 21 CFR 890.5290.