← Back to catalogue

QuadStar II

FDA UDI

Class II (US FDA UDI)

by BioMedical Life Systems Inc.

Identity

Trade Name
QuadStar II FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Model / Reference
QuadStar II FDA UDI

Identifiers

Catalog Number
KQST FDA UDI
Primary DI / UDI-DI
00857771003231 FDA UDI
510(k) Number
K041388 FDA UDI
FDA Product Code
LIH FDA UDI
IPF FDA UDI
GZJ FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
890.5850 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Height — 6 Inch FDA UDI
Length — 7 Inch FDA UDI
Width — 2 Inch FDA UDI

Category: Physical therapy transcutaneous neuromuscular electrical stimulation systemAnalgesic transcutaneous electrical nerve stimulation system

QuadStar II by BioMedical Life Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
BioMedical Life Systems Inc.

Sources (1)

  • FDA UDI e24bfe98-3b07-4cbc-8663-e5fdc5cbb85e 36 fields · synced Jun 8, 2026