Wfr/Aquaplast Corp.
United StatesFDA applicant, unverified
- Devices
- 8
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Wfr/Aquaplast Corp. makes
Wfr/Aquaplast Corp. manufactures medical devices for immobilization, positioning, and support in radiotherapy and wound care, including radiolucent headholders, radiotranslucent pelvic and belly boards, radiotherapy chairs, and customizable splints for nasal and palatal applications. Their product line also includes dressing tie-downs and IGRT treatment table tops with compatible inserts and accessories.
The company’s devices are regulated under FDA Class I and Class II classifications, with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Accufix Tilting Radiotranslucent Headholder Ref K021124
Regimes: 510(k) Registry: 510(k)Aquaplast Tie Down Dressing Ref K943871
Regimes: 510(k) Registry: 510(k)Qfix Radiotherapy Chair Ref K120916
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Aquaplast Ref K935067
Regimes: 510(k) Registry: 510(k)Aquaplast Palatal Stent Ref K973370
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Wfr/Aquaplast Corp., initiated on 2016-01-07. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 7 Jan 2016 Z-1264-2016 Class II Terminated Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the zero reference with respect to other Access ClearVue Prone Breast devices. This can result in differences in scale orientation.
Full distribution text
- 7 Jan 2016 Z-1264-2016 Class II Terminated Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the zero reference with respect to other Access ClearVue Prone Breast devices. This can result in differences in scale orientation.
Frequently asked questions
How many devices does Wfr/Aquaplast Corp. have in the registry?
The registry currently lists 8 devices for Wfr/Aquaplast Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wfr/Aquaplast Corp.'s devices?
Among its 8 most recently registered devices, Wfr/Aquaplast Corp. has devices listed in FDA 510(k) (8 devices).
What risk classes do Wfr/Aquaplast Corp.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Wfr/Aquaplast Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Wfr/Aquaplast Corp.?
FDA recall records list 1 recall initiated by Wfr/Aquaplast Corp., the most recent initiated on 7 Jan 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Wfr/Aquaplast Corp. in the registry?
The most recently registered devices listed for Wfr/Aquaplast Corp. include ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER, AQUAPLAST TIE DOWN DRESSING, QFIX RADIOTHERAPY CHAIR and KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS.