Innovative Health Solutions (Ihs), Inc.: FDA clearances and approvals
Innovative Health Solutions (Ihs), Inc. has 0 FDA 510(k) clearances, plus 2 De Novo decisions, across 2 product codes in 2 review panels.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PZR | Percutaneous Nerve Stimulator For Opioid Withdrawal | 1 | 0 |
| QHH | Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180057 | De Novo | Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) | 2019-06-07 |
| DEN170018 | De Novo | Percutaneous Nerve Stimulator For Opioid Withdrawal | 2017-11-15 |
Recalls
openFDA lists no recalls under a recalling firm named Innovative Health Solutions (Ihs), Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Innovative Health Solutions (Ihs), Inc. have?
Innovative Health Solutions (Ihs), Inc. has 0 FDA 510(k) clearances, plus 2 De Novo decisions, across 2 product codes in 2 review panels.
What devices does Innovative Health Solutions (Ihs), Inc. make?
Its most frequent FDA product codes are PZR (Percutaneous Nerve Stimulator For Opioid Withdrawal, 1); QHH (Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs), 1).
Has Innovative Health Solutions (Ihs), Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Innovative Health Solutions (Ihs), Inc. Related entities may recall under other names.
Next steps
- See all 0 Innovative Health Solutions (Ihs), Inc. clearances with predicates and recalls
- Run predicate analysis for product code PZR, Innovative Health Solutions (Ihs), Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.