ComfortWave

Basic Information

• Brand Name: ComfortWave
• Primary DI: 00850054883292
• Version / Model: CW-S10-Teal
• Company Name: Sidmar Manufacturing, Inc.
• Labeler DUNS: 840618011
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-28
• Public Version: 1
• Public Version Date: 2023-11-06
• Public Version Status: New
• Public Device Record Key: fb41fdc0-9757-4539-938e-67eaba9c732d

Device Description

ComfortWave Hydromassage Table, S10, Teal, Right Hand Control, 120 volt, 60 hertz

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66737	Dry hydro-massage system	An electrically-powered assembly of devices intended for large-area/whole-body massage using water jets but without wetting the patient. It includes a water tank with internal pump(s)/jets, a covering membrane which receives the water pressure, and controls (e.g., touchscreen). It may be a chair-like or bath-like device whereby the patient sits/lies on the membrane to receive therapy. The device is intended to be used in a healthcare facility for various physiotherapy/relaxation-based applications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850054883292	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]