IONTOPATCH
FDA 510(k) clearance K992708 · decided 2000-02-01
Clearance details
- K-number
- K992708
- Device name
- IONTOPATCH
- Applicant
- Birch Point Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-08-11
- Decision date
- 2000-02-01
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- EGJ
- Device class
- 2
- Regulation number
- 890.5525
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Roseville, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is a recall (Z-2196-2025) | LTS Therapy Systems, LLC | 2025-07-29 |
| IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch i recall (Z-2197-2025) | LTS Therapy Systems, LLC | 2025-07-29 |