FDA UDI
In Commercial Distribution
🇺🇸 United States
TM-400
DI: 04983087007932
·
Model: TM-400
·
ITO CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TM-400
- Primary DI
- 04983087007932
- Version / Model
- TM-400
- Catalog Number
- TM-400
- Company Name
- ITO CO., LTD.
- Labeler DUNS
- 690637194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 06066111-fe0b-46a4-9e8e-1fde8e106c25
Device Description
Traction Device
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| ITH | Equipment, Traction, Powered | Physical Medicine | 890.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14106 | Intermittent powered traction system | An assembly of devices designed to apply and relieve pre-set traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. It usually consists of a mains electricity (AC-powered) motor with a control unit to generate and regulate various intermittent mechanical forces (regular, progressive/regressive, cyclic), and a cord clamped to harnesses to transmit the force. Adjustable spreader bars attached to the control unit may be used to vary the angle at which the cord applies traction. The assembly may be table/wall-mounted for horizontal cervical and lumbar traction, or vertical cervical traction. It is used primarily to widen intervertebral spaces. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04983087007932 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081247 | 000 |