China Daheng Group, Inc.
ChinaFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What China Daheng Group, Inc. makes
China Daheng Group, Inc. manufactures diode laser therapy systems and dental laser therapy systems designed for medical and dental applications, including soft tissue treatments and therapeutic procedures.
These devices are classified as Class II under regulatory frameworks and are listed via the FDA’s 510(k) pathway. The company operates from the United States.
Catalogue
Diode Laser Therapy System Ref K102669
Regimes: 510(k) Registry: 510(k)Dental Laser Therapy System Ref K113212
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by China Daheng Group, Inc., initiated on 2013-07-15. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 15 Jul 2013 Z-1145-2014 Class II Terminated Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers
Frequently asked questions
How many devices does China Daheng Group, Inc. have in the registry?
The registry currently lists 2 devices for China Daheng Group, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list China Daheng Group, Inc.'s devices?
Among its 2 most recently registered devices, China Daheng Group, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do China Daheng Group, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for China Daheng Group, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for China Daheng Group, Inc.?
FDA recall records list 1 recall initiated by China Daheng Group, Inc., the most recent initiated on 15 Jul 2013. 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 China Daheng Group, Inc. in the registry?
The most recently registered devices listed for China Daheng Group, Inc. include DIODE LASER THERAPY SYSTEM and DENTAL LASER THERAPY SYSTEM.