SCIAN

Basic Information

• Brand Name: SCIAN
• Primary DI: 06974665668384
• Version / Model: FJ-MYY-001
• Company Name: Yongkang Youha Electric Appliance Co.,Ltd
• Labeler DUNS: 541069715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-10
• Public Version: 1
• Public Version Date: 2025-09-18
• Public Version Status: New
• Public Device Record Key: cbdc4454-4530-47ea-8e08-b23ca0316b75

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KMN	Chair And Table, Medical	General Hospital	880.6140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13607	Sitz bath chair	A dedicated device designed to be sat upon by a patient in a powered sitz bath for external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas. The seat of the device is typically open allowing jets of water to reach the sacral, coccyx, rectum, groin and vaginal areas. The device is also typically designed with a back rest, armrests, and a frame in soft plastic [e.g., polyethylene (PE)] materials to prevent undue pressure to the skin during therapy; it may be adaptable for a person with a disability.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974665668384	GS1