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Action Products, Inc.

Hagerstown, MD, US

ACTION PRODUCTS, INC. appears in FDA device records in Hagerstown, MD. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
4
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Action Products, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Action Products Incorporatedrecall

510(k) clearance history

FDA records hold 2 510(k) clearances for Action Products, Inc. between 1980 and 1981. The busiest year on record is 1980, with 1. The most recent is 1981, with 1.

Clearances by year, as a table
510(k) clearance decisions for Action Products, Inc., by decision year
YearClearances
19801
19811
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K811528RADIATION BOLUSJADSubstantially Equivalent
K801694FLOTATION PAD FOR OPERATING TABLEFMPSubstantially Equivalent

Registered establishments

FDA registered establishments for Action Products, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
11810471181047ACTION PRODUCTS, INC.954 Sweeney Dr, HAGERSTOWN, MD 21740 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-2237-2009Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polymer pad used during radiation therapy.Medical device intended for use by healthcare practitioners was incorrectly labeled. 1.0 cm thick pad was labeled as 0.5 cm thickness, and vice versa.Terminated
Z-2236-2009Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy.Medical device intended for use by healthcare practitioners was incorrectly labeled. 1.0 cm thick pad was labeled as 0.5 cm thickness, and vice versa.Terminated
Z-0709-04Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.Wheelchair seat may not properly support the user due to cracks in the plastic seat base.Terminated
Z-0812-03Twister(tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS.Stitching in wheelchair seat back is defective and may not support user.Terminated

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