Access Point Medical, LLC
Potomac, MD, US
Access Point Medical, LLC appears in FDA device records in Potomac, MD. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Access Point Medical, LLC between 2005 and 2007. The busiest year on record is 2005, with 3. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 3 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K063449 | DELUXE NEBULIZER | CAF | Substantially Equivalent | |
| K050281 | TRANSPORT SERIES TRANSPORT CHAIR | IOR | Substantially Equivalent | |
| K050280 | RUNABOUT WHEELCHAIR | IOR | Substantially Equivalent | |
| K050279 | AXS-1 LITE WHEELCHAIR | IOR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0155-2007 | Access Point Medical-Heavy Duty Rollator with Curved Back (rolling walker), Product Code RL12011, with seat, curved backrest, 8'' wheels with locks, maximum capacity 400 lbs.,and wire basket. Manufactured for Access Point Medical, St. Louis, MO. Made in China | The fork component on the wheel of the Rollator can break due to the use of incorrect manufacturing material and/or molding processes. | Terminated | ||
| Z-0154-2007 | Access Point Medical-Heavy Duty Rollator (rolling walker), Product Code RL12010HD, with seat, backrest, 8'' wheels with locks, maximum capacity 400 lbs.,and wire basket. Manufactured for Access Point Medical, St. Louis, MO. Made in China | The fork component on the wheel of the Rollator can break due to the use of incorrect manufacturing material and/or molding processes. | Terminated | ||
| Z-0205-2007 | Access Point Medical Canes, Quad Cane, Large Base - Gold, Product Code CN11070B, and Large Base - Chrome, Product Code CN11070C, both packaged 6/case. The responsible firm on the label is Access Point Medical, St. Louis, MO. | The canes were made of unacceptable materials and could break | Terminated | ||
| Z-0204-2007 | Access Point Medical Canes, Quad Cane, Small Base - Gold, Product Code CN11050B, and Small Base - Chrome, Product Code CN11050C, both packaged 6/case. The responsible firm is Access Point Medical, St. Louis, MO. | The canes were made of unacceptable materials and could break | Terminated | ||
| Z-0203-2007 | Access Point Medical Canes, Quad Cane, Medium Base (Gold, Chrome), Product Code CN11050, packaged 10/case. The responsible firm on the label is Access Point Medical, St. Louis, MO. | The canes were made of unacceptable materials and could break | Terminated | ||
| Z-0202-2007 | Access Point Medical Canes, Cane, Off-Set Crook w/Strap-Black, Product Code CN10051, packaged 20/case. The responsible firm is Access Point Medical, St. Louis, MO. | The canes were made of unacceptable materials and could break | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain