Alimed, LLC
Dedham, MA, US
ALIMED, LLC appears in FDA device records in Dedham, MA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Alimed, LLC between 1979 and 1996. The busiest year on record is 1982, with 4. The most recent is 1996, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 1 |
| 1982 | 4 |
| 1984 | 1 |
| 1992 | 1 |
| 1996 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K963527 | UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS | FMQ | Substantially Equivalent | |
| K963528 | ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) | FMQ | Substantially Equivalent | |
| K963526 | STRAP WEDGE | FMQ | Substantially Equivalent | |
| K920487 | MINI VIBRATOR | IRO | Substantially Equivalent | |
| K840156 | PROTECTA COAT SPONGES | IZZ | Substantially Equivalent | |
| K822650 | SUPER DONUT | KME | Substantially Equivalent | |
| K822651 | TOTAL FINGER FLEXION SPLINT | ILH | Substantially Equivalent | |
| K820516 | ARTERIAL CANALIZATION DEVICE | DQY | Substantially Equivalent | |
| K820517 | CONSTRUCTA FOAM | Substantially Equivalent | ||
| K801743 | PLASTAZOTE SHOE | KNP | Substantially Equivalent | |
| K791189 | ECHO CARDIOGRAM PAD | FNJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1218386 | 1218386 | ALIMED, LLC | 297 High St, DEDHAM, MA 02026 US | 2026 | and 36 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNOAccessories, Wheelchair
- ILDAdaptor, Dressing
- IKXAid, Transfer
- EAJApron, Leaded
- IWOApron, Protective
- NNWBag, Urine Collection, Leg, For External Use, Non-Sterile
- FNJBed, Manual
- KMEBedding, Disposable, Medical
- FOBBedpan
- IQBBelt, Wheelchair
- NODBoard, Arm (With Cover), Non-Sterile
- IMXBoard, Lap, Wheelchair
- BRYCabinet, Table And Tray, Anesthesia
- DQYCatheter, Percutaneous
- KQZComponent, Traction, Non-Invasive
- IODComponents, Exercise
- FMWCover, Mattress (Medical Purposes)
- KICCushion, Flotation
- IMPCushion, Wheelchair
- FMRDevice, Transfer, Patient, Manual
- GXBEsthesiometer
- IONExerciser, Non-Measuring
- IMMFootrest, Wheelchair
- KQWGoniometer, Nonpowered
- HSSHalter, Head, Traction
- KYSInsoles, Medical
- FSALift, Patient, Non-Ac-Powered
- IKYMattress, Flotation Therapy, Non-Powered
- KMIMonitor, Bed Patient
- FWZOperating Room Accessories Table Tray
- KNPOrthosis, Corrective Shoe
- OHIOrthosis, Foot Drop
- IQIOrthosis, Limb Brace
- IPYOrthosis, Lumbo-Sacral
- IPWOrthosis, Sacroiliac, Soft
- IMEPack, Hot Or Cold, Reusable
- OHYPill Crusher/Cutter
- FMPProtector, Skin Pressure
- FMQRestraint, Protective
- EAKScreen, Leaded, Operator Radiation Protector
- KPYShield, Protective, Personnel
- ILISling, Arm
- NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile
- ILHSplint, Hand, And Components
- IOYSupport, Arm
- IMSSupport, Head And Trunk, Wheelchair
- CCXSupport, Patient Position
- LWGSurgical Table Cushion
- BWNTable And Attachments, Operating-Room
- IZZTable, Radiographic, Non-Tilting, Powered
- PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
- IROVibrator, Therapeutic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1407-2010 | Product is a pull cord type monitor, bed patient alarm used to detect patient/resident movement. An adjustable cord is attached to both the alarm and the patient. When the patient moves beyond the length of the cord the pin is pulled and the alarm activated. | Alimed became aware of issue via internal receiving inspection activities on 1/20/09. Firm states that subsequent to this observation, Customer Dissatisfaction inquiry #100192 was generated on 1/22/10. A single unit was received back by AliMed and 0 n/2/1/20 from a rehabilitation center that indicated that it had received a unit and it did not function upon its initial use. Failure of the alarm | Terminated | ||
| Z-0599-2009 | Alimed Gait Belt (Transfer Aid) Antimicrobial Plastic Buckle, 70" Model: 72109 | Misassembled gait (transfer aid) belt. | Terminated | ||
| Z-0598-2009 | Alimed Gait Belt (Transfer Aid), Antimicrobial Plastic buckle, 54" Model: 72108 | Misassembled gait (transfer aid) belt. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain