PHS - XS

Basic Information

• Brand Name: PHS - XS
• Primary DI: 04041925006117
• Version / Model: GBS 01.YY.ZZ
• Catalog Number: A008-685
• Company Name: medica - Medizintechnik GmbH
• Labeler DUNS: 328011325
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-14
• Public Version: 1
• Public Version Date: 2024-11-22
• Public Version Status: New
• Public Device Record Key: f21a760e-a736-4f01-8c76-5953a490781f

Device Description

The PHS is a support belt for weight relief, stabilization and fall protection for patients in therapeutic training equipment, e.g. for gait training, treadmills or ceiling systems. The attachment points are located above the head and stabilization points at hip height.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKK	System, Isokinetic Testing And Evaluation	Physical Medicine	890.1925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37480	General-purpose patient lifting system sling/harness	A general-purpose lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position with their body (back, arms, buttocks and upper legs) held within the sling for transfer and (re)positioning. It is typcially constructed of straps, belts and material in which the occupant is cradled and contained during the lifting process; some types may employ additional straps, belts or vest-like harnesses to safely secure the occupant within the device. It typically has lifting straps or eyes that attach to a two-point, three-point or four-point spreader bar. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04041925006117	GS1