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Wearable Antenna Assembly

FDA UDI

Class II (US FDA UDI)

by Stimwave Technologies Incorporated

Identity

Trade Name
Wearable Antenna Assembly FDA UDI
Generic Name
Implantable spinal cord electrical stimulation system programmer FDA UDI
Device Name
Wearable Antenna Assembly/StimQ Wearable Antenna Gear FDA UDI
Model / Reference
PDBT-915-2K FDA UDI
Description
Wearable Antenna Assembly/StimQ Wearable Antenna Gear FDA UDI

Identifiers

Primary DI / UDI-DI
00818225020150 FDA UDI
FDA Product Code
GZF FDA UDI
GZB FDA UDI
GMDN Term
Implantable spinal cord electrical stimulation system programmer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5870 FDA UDI
882.5880 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Multiple active implantable device programmerImplantable spinal cord electrical stimulation system programmer

Wearable Antenna Assembly by Stimwave Technologies Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable spinal cord electrical stimulation system programmer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stimwave Technologies Incorporated

Sources (1)

  • FDA UDI d915c0ea-0d13-44aa-9061-65de270bbacc 34 fields · synced May 30, 2026