Health Care Mfg., Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Health Care Mfg., Inc.” (first 1995, latest 2002), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 71 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| INQ | Table, Powered | 4 | 4 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
| ITH | Equipment, Traction, Powered | 1 | 1 |
Review panels
- Physical Medicine (5)
- Radiology (2)
Most recent Health Care Mfg., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022737 | HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC | KPR | 2002-10-22 | 64 |
| K022667 | HCMI X-RAY | KPR | 2002-10-22 | 71 |
| K952441 | LEGEND | INQ | 1995-06-19 | 25 |
| K951323 | VH-2000 | INQ | 1995-06-07 | 76 |
| K951382 | HLT 406 | INQ | 1995-06-01 | 66 |
| K944699 | ATT-300 | ITH | 1995-05-26 | 245 |
| K944329 | BACK SPECIALIST | INQ | 1995-03-15 | 190 |
Recalls
openFDA lists no recalls under a recalling firm named Health Care Mfg., Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Health & Life Co., Ltd. (60 510(k)s)
- Health Products, Inc. (13 510(k)s)
- Health Line International Corporation (12 510(k)s)
- Health Hero Network, Inc. (8 510(k)s)
- Health Care Innovations, Inc. (5 510(k)s)
- Health Development Corp. (5 510(k)s)
- Health Images, Inc. (5 510(k)s)
- Health Beacons, Inc. (4 510(k)s)
- Health Improvement Assoc. (4 510(k)s)
- Health Scan, Inc. (4 510(k)s)
- Health Sense Intl., Inc. (4 510(k)s)
- Health Systems Intl., Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Health Care Mfg., Inc.?
FDA lists 7 510(k) clearances under the applicant name “Health Care Mfg., Inc.” (first 1995, latest 2002), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Health Care Mfg., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Health Care Mfg., Inc. is 71 days.
Which FDA product codes appear under Health Care Mfg., Inc.?
The most frequent FDA product codes under this applicant name are INQ (Table, Powered, 4); KPR (System, X-Ray, Stationary, 2); ITH (Equipment, Traction, Powered, 1).
Next steps
- See all 7 Health Care Mfg., Inc. clearances with predicates and recalls
- Run predicate analysis for product code INQ, Health Care Mfg., Inc.'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.