CareWear ®

Basic Information

• Brand Name: CareWear ®
• Primary DI: 04719872330479
• Version / Model: CWC-1
• Company Name: ZMI ELECTRONICS LTD.
• Labeler DUNS: 657406062
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-26
• Public Version: 4
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 665308bb-98e6-4480-a9c5-c50ce9f021c4
• Distribution End Date: 9999-12-31

Device Description

The first wearable, wireless LED light patches for athletes in all sports: on the training field, on the road, even at home. CareWear Light Patches start relieving pain and accelerating recovery in just 30 minutes.

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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60410	Musculoskeletal/physical therapy laser, home-use	An electrically-powered diode laser intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, rheumatism, disorders of the joints and soft/connective tissues), improvement of local blood/lymph circulation to facilitate healing/reduce swelling (e.g., lymphoedema therapy), or for non-needle acupuncture. It typically consists of a hand-held applicator designed for transcutaneous delivery of visible red/infrared laser light energy. It is intended to be operated by a patient/layperson in the home, typically under healthcare professional guidance.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	44719872330491	GS1	carry case	4	Not in Commercial Distribution	2019-07-26
Primary	04719872330479	GS1
Package	14719872330483	GS1	carry case	1	Not in Commercial Distribution	2019-07-26
Package	04719872330585	GS1	carry case & sleeve	4	In Commercial Distribution	9999-12-31
Package	04719872330578	GS1	Carry case & sleeve	1	In Commercial Distribution	9999-12-31

Customer Contacts

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