FDA UDI
In Commercial Distribution
🇺🇸 United States
G5®
DI: 00746980001414
·
Model: TS240W
·
GENERAL PHYSIOTHERAPY INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- G5®
- Primary DI
- 00746980001414
- Version / Model
- TS240W
- Catalog Number
- TS240W
- Company Name
- GENERAL PHYSIOTHERAPY INC
- Labeler DUNS
- 098639974
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-26
- Public Version
- 5
- Public Version Date
- 2020-09-29
- Public Version Status
- Update
- Public Device Record Key
- 67cab76c-8a9c-4cb5-997b-66e82fe9c20b
Device Description
The G5 TherAssist is our latest advancement in massage/percussion technology for use in both physical and respiratory therapy applications. The TherAssist is ideal for use in physical therapy, respiratory therapy, and sports medicine applications. This unit features digital solid-state electronic controls. Includes a timer. An expanded cycle per second range (10 - 60 CPS) more closely replicates manual procedures. Ideal for stress reduction, myofascial release, sports rehabilitation, deep muscle therapy, trigger point reduction, treatment of muscle spasm, pain relief by mobilizing lactic acid, and postural drainage.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35538 | Large-area electric massager | An electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may utilize vibrating belts or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment. This device is intended for use in healthcare facilities and is not applicable to home therapies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00746980001414 | GS1 |
Customer Contacts
- Phone
- 1-800-237-1832
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 38 | Pound |