Wellspring Pharmaceutical Corporation
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Wellspring Pharmaceutical Corporation makes
Wellspring Pharmaceutical Corporation manufactures Bonine Acupressure Bands, a non-pharmaceutical device designed for temporary relief of nausea and vomiting associated with motion sickness.
The Bonine Acupressure Bands are classified as Class II under the FDA’s regulatory framework and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Bonine Acupressure Bands Ref K211823
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Wellspring Pharmaceutical Corporation, initiated on 2014-03-25. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 25 Mar 2014 Z-2112-2014 Class I Terminated Potential for microbial contamination of the product.
Full distribution text
- 25 Mar 2014 Z-2112-2014 Class I Terminated Potential for microbial contamination of the product.
Frequently asked questions
How many devices does Wellspring Pharmaceutical Corporation have in the registry?
The registry currently lists 1 device for Wellspring Pharmaceutical Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wellspring Pharmaceutical Corporation's devices?
Among its 1 most recently registered device, Wellspring Pharmaceutical Corporation has devices listed in FDA 510(k) (1 device).
Are there FDA recall records for Wellspring Pharmaceutical Corporation?
FDA recall records list 1 recall initiated by Wellspring Pharmaceutical Corporation, the most recent initiated on 25 Mar 2014. 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 Wellspring Pharmaceutical Corporation in the registry?
The most recently registered devices listed for Wellspring Pharmaceutical Corporation include Bonine Acupressure Bands.