Data / Medical devices / United States / Assembly Required Di
Assembly Required Di: FDA-registered device maker in Mount Sinai, NY, United States, 1 510(k) clearance
Assembly Required Di is registered with the FDA (registration 2437956) in Mount Sinai, NY, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 9, 1997. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2437956
- FEI number
- 3002357954
- Address
- 5507 Nesconset Hwt. #10 Ste 336, Mount Sinai, NY, United States, 11766
- Owner or operator
- ASSEMBLY REQUIRED DIST. (9031473)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- December 5, 2007
- Registered through
- 2027
- Brand names listed
- CLM Instrument Trolley, CLM Pillcrusher, Qualine WC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pill Crusher/Cutter | OHY | 1 | Contract manufacturer | accessdata.fda.gov |
| Table, Instrument, Manual, Ophthalmic | HRK | 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 |
|---|---|---|---|---|---|---|
| October 9, 1997 | K973418 | UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4) | IOR | Substantially Equivalent | Assembly Required Dist., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Table, Instrument, Manual, Ophthalmic
- All makers of Wheelchair, Mechanical
- All makers of Pill Crusher/Cutter
Updated October 9, 1997. 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.