FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
IB-Stim
K Number: DEN180057
·
Decision Jun 7, 2019
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
4
Applicant Total
2
Review Days
225
Basic Information
- Device Name
- IB-Stim
- K Number
- DEN180057
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.5340
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Innovative Health Solutions (IHS), Inc.
- Date Received
- October 25, 2018
- Decision Date
- June 7, 2019
- Product Code
- QHH
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- NE
- 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.
NeurAxis IB-Stim (01-1020)
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NeurAxis IB-Stim (01-1020)
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TEA Device
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FDA Class 2
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First Relief v1
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FDA Class 2
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Other Clearances by Innovative Health Solutions (IHS), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN170018 | NSS-2 System | Nov 15, 2017 | Unknown |