510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Little Rapids Corporation

Green Bay, WI, US

Little Rapids Corporation appears in FDA device records in Green Bay, WI. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Little Rapids Corporation in 2022.

Clearances by year, as a table
510(k) clearance decisions for Little Rapids Corporation, by decision year
YearClearances
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K220377Procedure MaskFXXSubstantially Equivalent

Registered establishments

FDA registered establishments for Little Rapids Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
21823031000049086Little Rapids Corporation2273 Larsen Rd, GREEN BAY, WI 54303 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0578-2018EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3The secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer. The product is designed for patient transfer, not lifting. However, we recognize that the product may be utilized outside of its intended design scope, and lifting may occur. Lifting could lead tearing of the equipment cover and the potential for patient falling through.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain