XBody Newave USA

by Xbody Hungary Kft.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 22 Oct 2026

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	Number05999860571001 UDI-DI	Date31 Jul 2019Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: XBody
Generic Name: Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / Reference: Newave USA

Primary DI / UDI-DI: 05999860571001
510(k) Number: K190038
FDA Product Code: NGX
GMDN Term: Physical therapy transcutaneous neuromuscular electrical stimulation system

Device Class: Class II
Regulation Number: 890.5850
GUDID distribution status: In Commercial Distribution

Other devices from Xbody Hungary Kft.

Properties

Serial Number
Manufacturing Date

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
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No