IONTOPATCH— 510(k) K992708
Substantially EquivalentBirch Point Medical, Inc.
FDA 510(k) clearance K992708 for IONTOPATCH, Substantially Equivalent on 2000-02-01. Applicant: Birch Point Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Birch Point Medical, Inc.
- Product code
- Code EGJ
- Device class
- Class 2
- Regulation
- 21 CFR 890.5525
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roseville, MN, US
Recent devices under product code EGJ
view allRecalls naming K992708
K-number listed on FDA's recall record- Z-2196-2025 — IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
- Z-2197-2025 — IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
- Z-0454-2022 — iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992708.
Data sourced from openFDA. This site is unofficial and independent of the FDA.