← Back to catalogue

Medical Science Products

FDA UDI

Class II (US FDA UDI)

by Sauvre International, Ltd.

Identity

Trade Name
Medical Science Products FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
Analog TENS device FDA UDI
Model / Reference
COM-TENS FDA UDI
Description
Analog TENS device FDA UDI

Identifiers

Catalog Number
COM-TENS FDA UDI
Primary DI / UDI-DI
00851610008326 FDA UDI
510(k) Number
K071624 FDA UDI
FDA Product Code
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
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

No

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

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 90 Millimeter FDA UDI
Width — 65 Millimeter FDA UDI
Weight — 120 Gram FDA UDI
Height — 20 Millimeter FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

Medical Science Products by Sauvre International, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Cleared under the same submission

K071624 also covers:

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
Sauvre International, Ltd.

Sources (1)

  • FDA UDI 5b73e5fe-8c99-47d5-8736-50eda0d82bc3 37 fields · synced Jun 6, 2026