ActiPatch

Basic Information

• Brand Name: ActiPatch
• Primary DI: 00851329005340
• Version / Model: 088
• Catalog Number: 720-4
• Company Name: Bioelectronics Corporation
• Labeler DUNS: 101591571
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-23
• Public Version: 4
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 0e8d8ad6-ed54-4649-9768-3d7b9ac17b72
• Distribution End Date: 2025-07-23

Device Description

Back, Knee, Muscle & Joint Advanced Long-Lasting Relief.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
PQY	Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain	Physical Medicine	890.5290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35169	Hand-held deep-tissue electromagnetic stimulator	A battery-powered, hand-held device designed to apply an electromagnetic (EM) field to body deep tissues to help reduce pain associated with musculoskeletal/neurological disorders (e.g., arthritis, sciatica) and/or to treat soft-tissue wounds and injuries with no production of a therapeutic deep heat. It is a self-contained electronic unit with controls intended to be applied to the body to emit short-time pulsed, radio-frequency energy [pulsed electromagnetic fields (PEMF)] to tissues at a level below the patient's heat sensory perception threshold. It is not intended to apply an electric current directly to the body. The device is intended to be used in clinical and home settings.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851329005340	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -13 – 158 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal