Model: 1.0
Catalog: Pro-HL
DI: 07290020483089
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-06
Current Version: 2026-05-14
Description
SACS PRO
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b0fa477d-ed06-4123-b482-1dedee0f9610
Distribution Status:
In Commercial Distribution
DUNS Number:
600461703
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Carton
Item #1 - Device ID:
17290020483086
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
07290020483089
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
07290020483089
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 67203
Name: Wearable electric massager
Definition:
An electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It is typically in the form of a wearable wrap containing vibrating nodes that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This is a home-use device.
FDA Product Codes
IRP
Massager, Powered Inflatable Tube
Premarket Submissions
Submission Number:
K243177
Supplement Number:
000