Med-Mizer, Inc.
Batesville, IN, US
MED-MIZER, INC appears in FDA device records in Batesville, IN. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004976058 | 3004976058 | MED-MIZER, INC | 80 COMMERCE DRIVE, BATESVILLE, IN 47006 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1205-2023 | Sit to Stand STS500 Patient Lift | Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side. | Class II | Open, Classified | |
| Z-1204-2023 | Med-Riser MR600 Patient Lift | Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side. | Class II | Open, Classified | |
| Z-3183-2018 | PR1000 Pivot Rehab Bed AC powered adjustable bed. | Under certain conditions, when pivoting bed to the extreme left there are situations where the wire/cables may become pinched. A failure would result in the resident requiring to be transferred to a different bed until repairs can be made | Class II | Terminated | |
| Z-1543-2014 | RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care. | All configurations of the SS Retractabed, Clinical Contour, made prior to June 7, 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on t | Class II | Terminated | |
| Z-1542-2014 | RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care. | All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on th | Class II | Terminated | |
| Z-1541-2014 | RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care. | All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on th | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain