Commwell PhysioGlove ET System

by Commwell Research & Development Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07290012672026 UDI-DI	Date25 Jan 2017Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Commwell
Generic Name: Multichannel electrocardiograph, noninterpretive
Model / Ref / Catalog: PhysioGlove ET System, 5-056-00

Primary DI / UDI-DI: 07290012672026
510(k) Number: K133703
FDA Product Code: DPS
GMDN Term: Multichannel electrocardiograph, noninterpretive

Device Class: Class II
Regulation Number: 870.2340
GUDID distribution status: In Commercial Distribution

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Properties

Prescription Use
Serial Number
Manufacturing Date

Other properties (11)

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