Data / Medical devices / United States / Action Products, Inc.
Action Products, Inc.: FDA-registered device maker in Hagerstown, MD, United States, 1 510(k) clearance
Action Products, Inc. is registered with the FDA (registration 1181047) in Hagerstown, MD, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 10, 1981. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1181047
- Address
- 954 Sweeney Dr, Hagerstown, MD, United States, 21740
- Owner or operator
- ACTION PRODUCTS, INC. (1181047)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 21, 2000
- Registered through
- 2027
- Brand names listed
- Action Brand Bolus, Action Brand Hand Exerciser, Various models, Action Brand Mattress Overlays, w/ & w/o hitch, Action Brand Skinless Bolus, Action® Adaptive Pads, Various Series, Action® Angel Stretcher Pads, Action® Cushions, Various Series, Action® Disposable Covers, Various and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | 1 | Manufacturer | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Manufacturer | accessdata.fda.gov |
| Exerciser, Non-Measuring | ION | 1 | Manufacturer | accessdata.fda.gov |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 | Manufacturer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| System, Therapeutic, X-Ray | JAD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 10, 1981 | K811528 | RADIATION BOLUS | JAD | Substantially Equivalent | Action Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 26, 2009 | 53041 | Not yet classified | Terminated | Action 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. | accessdata.fda.gov |
| February 2, 2004 | 28201 | Not yet classified | Terminated | Xact(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. | accessdata.fda.gov |
| February 25, 2003 | 25755 | Not yet classified | Terminated | Twister(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. | accessdata.fda.gov |
Compare with other makers
- All makers of Cushion, Flotation
- All makers of Exerciser, Non-Measuring
- All makers of Mattress, Flotation Therapy, Non-Powered
- All makers of Bedding, Disposable, Medical
- All makers of Protector, Skin Pressure
- All makers of System, Therapeutic, X-Ray
Updated September 22, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.