Who else makes this device?

Name: Solar Compact
Brand: Solar Compact

Gastroenterology & Urology › DiagnosticSystem, Gastrointestinal Motility (Electrical)

Solar Compact

Catalogue number G4-1, listed by Laborie Medical Technologies Corp., United States, under System, Gastrointestinal Motility (Electrical). 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

2510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FFX
Manufacturer	City	Province	Registered as	Device types
Ankon Medical Technologies (Shanghai) Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	2

Record

Regulatory record for Solar Compact
Listed by	Laborie Medical Technologies Corp., United States
FDA product code	FFX
Device type	System, Gastrointestinal Motility (Electrical)
Device class	Class 2
Regulation	21 CFR 876.1725
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2025-03-06

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Solar Compact
Catalogue number	Size	Status
G4-1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Mui Scientific	H&A Mui Enterprises, Inc.	771
UniTip High Resolution Catheter	Unisensor AG	183
UniTip Catheter	Unisensor AG	100
ManoScan	Given Imaging Ltd.	60
Diversatek Healthcare	Diversatek Healthcare Inc	27
inSIGHT Ultima	Diversatek Healthcare Inc	19
Endoflip	Covidien LP	17
Sitzmarks Radiopaque Markers	Konsyl Pharmaceuticals, Inc.	14
Zvu®	Diversatek Healthcare Inc	11
Distender II Barostat	G & J Electronics, Inc.	9
PriZm	Diversatek Healthcare Inc	8
ManoView	Given Imaging Ltd.	6

Showing 12 of 107. All products under System, Gastrointestinal Motility (Electrical)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K240007	2024-05-06
K963064	1997-06-05

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2026-05-21	Class II	Device Design	Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system’s internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulat	372 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.