Stimfit 1.03

by Valmed Corp.

Stimfit 1.03 is a Class II device made by Valmed Corp., cleared under FDA 510(k) K031611 on 29 Sep 2004 and listed in FDA GUDID since 28 Nov 2016 (UDI-DI 07640174840007), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07640174840007 UDI-DI	Date28 Nov 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK031611	Date29 Sep 2004Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07640174840007
FDA 510(k) database 510(k) number K031611

Across registries

2 registries list this device

FDA 510(k) K031611 decided 29 Sep 2004 Active
FDA GUDID UDI-DI 07640174840007 listed 28 Nov 2016 Listed

Timeline

2 dated events

29 Sep 2004 Cleared FDA 510(k) K031611
28 Nov 2016 Listed FDA GUDID 07640174840007

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Stimfit
Generic name: Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / reference: 1.03

Primary DI / UDI-DI: 07640174840007
510(k) Number: K031611
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

Similar devices in this category

Other devices filed under Physical therapy transcutaneous neuromuscular electrical stimulation system.

Other devices from Valmed Corp.

See all devices from Valmed Corp. →

Properties

Over-the-counter
Serial number

Other properties (13, all answered No)