Pwn Health Chicago, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Pwn Health Chicago, LLC”, plus 1 PMA decision, across 1 product code. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QRO | 1 | 0 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P980046 | PMA | HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS | 1999-04-28 |
Recalls
openFDA lists no recalls under a recalling firm named Pwn Health Chicago, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Pwn Health Chicago, LLC?
FDA lists 0 510(k) clearances under the applicant name “Pwn Health Chicago, LLC”, plus 1 PMA decision, across 1 product code. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Pwn Health Chicago, LLC?
The most frequent FDA product codes under this applicant name are QRO (device, 1).
Next steps
- See all 0 Pwn Health Chicago, LLC clearances with predicates and recalls
- Run predicate analysis for product code QRO, Pwn Health Chicago, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.