FX635 Hps
FX635 Hps is a Class II device made by Erchonia Corporation, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00858985006049), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00858985006049 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00858985006049
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- FX635
- Generic name
- Musculoskeletal/physical therapy laser, professional
- Model / Ref / Catalog
- HPS
- Primary DI / UDI-DI
- 00858985006049
- FDA product code
- NHN
- GMDN term
- Musculoskeletal/physical therapy laser, professional
- Device class
- Class II
- Regulation number
- 890.5500
- GUDID distribution status
- In Commercial Distribution
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