NA TM-400 Treadmill

by Edan Instruments, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06944413808164 UDI-DI	Date7 Dec 2017Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Cardiopulmonary stress exercise trolley
Model / Reference: TM-400 Treadmill

Primary DI / UDI-DI: 06944413808164
FDA Product Code: IOL
GMDN Term: Cardiopulmonary stress exercise trolley

Device Class: Class I
Regulation Number: 890.5380
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Premarket Exempt
Serial Number
Manufacturing Date

Other properties (10)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No
Expiration Date: No