FDA UDI
In Commercial Distribution
🇺🇸 United States
D function
DI: 04983087012394
·
Model: D function
·
ITO CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- D function
- Primary DI
- 04983087012394
- Version / Model
- D function
- Company Name
- ITO CO., LTD.
- Labeler DUNS
- 690637194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-09
- Public Version
- 3
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- e21233af-a22a-4200-8bb9-0cec8844d380
Device Description
Dual Channel Electrical Muscle Stimulator for TMJ Pain Relief
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 |
|---|---|---|---|---|
| NUW | Stimulator, Muscle, Powered, Dental | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47555 | Mastication muscle electrical stimulation system | An assembly of devices designed to apply electrical stimuli to the mastication and facial muscles. It typically consists of an electrical pulse generator, appropriate active electrodes that are usually placed on the coronoid notches of the mandible, and a common return electrode located at the nape of the neck below the hairline. The device is typically used in dentistry to relax the facial and mastication muscles to treat temperomandibular joint (TMJ) dysfunction and associated pain, to relieve symptoms associated with muscle spasm, to take occlusal registrations and denture impressions, and for other therapeutic measures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04983087012394 | GS1 | ||||
| Package | 24983087012398 | GS1 | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203525 | 000 |