Data / Medical devices / United States / Karman Healthcare Inc.
Karman Healthcare Inc.: FDA-registered device maker in City Of Industry, CA, United States, 1 510(k) clearance
Karman Healthcare Inc. is registered with the FDA (registration 2085336) in City Of Industry, CA, United States. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 25, 2000. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2085336
- FEI number
- 1000306460
- Address
- 19255 San Jose Ave, City Of Industry, CA, United States, 91748
- Owner or operator
- KARMAN HEALTHCARE, INC. (9011011)
- Roles
- Repackager or relabeler
- First device listed
- December 24, 2008
- Registered through
- 2026
- Brand names listed
- Karman
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Armrest, Wheelchair | IML | 1 | Repackager or relabeler | accessdata.fda.gov |
| Attachment, Commode, Wheelchair | INB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cushion, Wheelchair | IMP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Device, Anti-Tip, Wheelchair | IMR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Footrest, Wheelchair | IMM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handrim, Wheelchair | IMO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tips And Pads, Cane, Crutch And Walker | INP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 25, 2000 | K002202 | KARMAN WHEELCHAIR | IOR | Substantially Equivalent | Karman Healthcare, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 27, 2016 | 73159 | Class II | Terminated | Karma Flexx Wheelchair Manual Wheelchair. | Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets. | accessdata.fda.gov |
Compare with other makers
- All makers of Attachment, Commode, Wheelchair
- All makers of Device, Anti-Tip, Wheelchair
- All makers of Accessories, Wheelchair
- All makers of Footrest, Wheelchair
- All makers of Walker, Mechanical
- All makers of Armrest, Wheelchair
Updated August 25, 2000. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.