Catalogue number HHP2020-001, listed by Curbell Medical Products, Inc., United States, under System, Environmental Control, Powered. 1 manufacturer in China is registered for this product code.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Handheld PENDANT,2020,N,RM/RD Lts,led’s | Listed by | Curbell Medical Products, Inc., United States |
| FDA product code | IQA |
| Device type | System, Environmental Control, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3725 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number, manufacturing date |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.