Essential Medical Supply, Inc.
Winter Park, FL, US
Essential Medical Supply, Inc. appears in FDA device records in Winter Park, FL. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Essential Medical Supply, Inc. in 1994.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2269-2010 | ESSENTIAL MEDICAL SUPPLY, INC. ENDURANCE HD, BUILT TO LAST, HEAVY DUTY FOUR WHEEL WALKER for users up to 500 pounds. Model W1801B- Blue, UPC 7 54756 91802 6 all serial numbers. W1801R-Red, UPC 7 54756 91803 3 all serial numbers. The Endurance HD is a four wheeled steel frame walker with loop locking wheel locks, a padded seat and an under seat tote for carrying personal articles. Used to assist in ambulation and specifically for obese patients weighing up to 500 pounds. Warranty Card: "...lifetime of the original purchaser...". Usable life of a walker is 5 years but firm will warranty for lifetime of the original purchaser. | Essential Medical Supply, Inc. is recalling W1801B and W1801R Endurance HD Walkers due to recent reports and tests that show the front caster may detach from the frame. The potential failures include a collapse of the plastic fork or shearing of the stud attaching the caster to the frame. | Terminated | ||
| Z-1674-2009 | Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator | The caster may separate from the frame completely causing injury to the user. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain