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Replexa+ Treatment Applicator

FDA UDI

Class II (US FDA UDI)

by Promedtek, Inc.

Identity

Trade Name
Replexa+ Treatment Applicator FDA UDI
Generic Name
Short-wave diathermy treatment system, professional FDA UDI
Device Name
Replexa+ Model C1416 Shortwave Diathermy Treatment Applicator FDA UDI
Model / Reference
C1416 FDA UDI
Description
Replexa+ Model C1416 Shortwave Diathermy Treatment Applicator FDA UDI

Identifiers

Primary DI / UDI-DI
00850886008016 FDA UDI
510(k) Number
K162240 FDA UDI
FDA Product Code
IMJ FDA UDI
GMDN Term
Short-wave diathermy treatment system, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5290 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Short-wave diathermy treatment system, professional

Replexa+ Treatment Applicator by Promedtek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Short-wave diathermy treatment system, professional.

Cleared under the same submission

K162240 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Promedtek, Inc.

Sources (1)

  • FDA UDI abaf862d-4e8f-48d0-8975-4db6298a1968 35 fields · synced Jun 6, 2026