FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEA Device
K Number: K230526
·
Decision Sep 14, 2023
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
5
Applicant Total
2
Review Days
199
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Basic Information
- Device Name
- TEA Device
- K Number
- K230526
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5340
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Transtimulation Research, Inc.
- Date Received
- February 27, 2023
- Decision Date
- September 14, 2023
- Product Code
- QHH
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QHH | Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QHH), ordered by most recent decision date.
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Other Clearances by Transtimulation Research, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243613 | Patch-TEA (Model TRI-21) | Apr 9, 2025 | Substantially Equivalent |