Soundfuse UR410-Bk

by HongKong Pishon Medical Equipment Co., Limited 2 variants

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number14895262504280 UDI-DI	Date22 Apr 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Soundfuse
Generic Name: Handgrip disability-assistive walker, non-powered, non-foldable
Model / Reference: UR410-BK

Primary DI / UDI-DI: 14895262504280
FDA Product Code: ITJ
GMDN Term: Handgrip disability-assistive walker, non-powered, non-foldable

Device Class: Class I
Regulation Number: 890.3825
GUDID distribution status: In Commercial Distribution

Other devices from HongKong Pishon Medical Equipment Co., Limited

Soundfuse UR410-Rd

Class I
Soundfuse UR410-Cp

Class I
Soundfuse UR410-Bl

Class I
Homland R16-Pu

Class I
Homland R16-Rr

Class I
Homland R16-Bl

Class I

See all devices from HongKong Pishon Medical Equipment Co., Limited →

Properties

Premarket Exempt
Lot / Batch Number

Other properties (12)

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