Community Products, LLC
Rifton, NY, US
Community Products, LLC appears in FDA device records in Rifton, NY. FDA records list no 510(k) clearances, no PMA records and 3 registered establishments. As of , FDA records show 7 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 |
|---|---|---|---|---|---|
| 1319558 | 1000120230 | COMMUNITY PRODUCTS, LLC | Platte Clove Road, ELKA PARK, NY 12427 US | 2026 | |
| 1319061 | 1319061 | Community Products, LLC | 103 Woodcrest Drive, RIFTON, NY 12471 US | 2026 | |
| 3010761454 | 3010761454 | Community Products, LLC | 100 Spring Valley Rd, Farmington, PA 15437 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-1139-2026 | Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion. | Potential for fraying on the body support strap. | Class II | Open, Classified | |
| Z-1138-2026 | Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that the legs fit underneath beds. | Potential for fraying on the body support strap. | Class II | Open, Classified | |
| Z-1137-2026 | Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. | Potential for fraying on the body support strap. | Class II | Open, Classified | |
| Z-0166-2020 | Rifton E-Pacer, SKU K660, powered lift device | A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use. | Class II | Terminated | |
| Z-0165-2020 | Rifton TRAM Low Base, SKU K320, powered lift device | A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use. | Class II | Terminated | |
| Z-0164-2020 | Rifton TRAM Standard Base, SKU K310, powered lift device | A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use. | Class II | Terminated | |
| Z-0318-2009 | Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic buckle. 510(k) exempt, Medical Device Listing # R061877. The product is used as a hip strap chair for children. | Some hip straps were assembled incorrectly by threading the buckle on the strap upside down. If a child were left unattended in spite of the warnings on the product and in the manual, a defective hip strap could loosen, allowing the child to slip down in the chair and this could create a choking hazard. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain