Wearable Antenna Assembly

Basic Information

• Brand Name: Wearable Antenna Assembly
• Primary DI: 00818225020150
• Version / Model: PDBT-915-2K
• Company Name: STIMWAVE TECHNOLOGIES INCORPORATED
• Labeler DUNS: 078294927
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-25
• Public Version: 2
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: d915c0ea-0d13-44aa-9061-65de270bbacc

Device Description

Wearable Antenna Assembly/StimQ Wearable Antenna Gear

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• 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
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	882.5870	2
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	882.5880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61588	Implantable spinal cord electrical stimulation system programmer	A battery-powered external device designed to change, telemetrically, one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator (EPG). It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It will typically also provide historic and/or current information regarding the performance of the implant.	No	Active
61393	Multiple active implantable device programmer	An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818225020150	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 140 Degrees Fahrenheit