FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 1 results

510(k) Data Aggregation

K Number

Device Name

ERCHONIA PL2000

Manufacturer

TUCO INNOVATIONS, INC.

Date Cleared

2002-01-17

(161 days)

Product Code

NHN

Regulation Number

890.5500

Why did this record match?

Applicant Name (Manufacturer) :

TUCO INNOVATIONS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The TUCO Erchonia PL2000 is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Device Description

Not Found

Ask a Question

Page 1 of 1