FDA UDI
In Commercial Distribution
🇺🇸 United States
Alpha-Stim AID
DI: 00857869005017
·
Model: AID
·
Electromedical Products International, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Alpha-Stim AID
- Primary DI
- 00857869005017
- Version / Model
- AID
- Catalog Number
- 500KIT
- Company Name
- Electromedical Products International, Inc.
- Labeler DUNS
- 610954729
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-08-25
- Public Version
- 6
- Public Version Date
- 2026-04-24
- Public Version Status
- Update
- Public Device Record Key
- fa0aa50e-2265-4c11-be0c-b261ccf4e207
Device Description
Alpha-Stim AID kit - China
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| QJQ | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | Neurology | 882.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61022 | Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system | An assembly of portable, battery-powered devices designed to apply noninvasive cranial electrical stimulation (CES) via cranial/peripheral nerves in/around the external ear for the treatment of one or more psychiatric and stress-related disorders (e.g., anxiety, depression, insomnia, migraine); it might additionally be intended for the treatment of autoimmune diseases (e.g., rheumatoid arthritis). It consists of an external pulse generator (EPG) with controls/display, and transcutaneous electrodes for placement on the skin surface in/around the external ear. The device may be used in conjunction with a smartphone for use by a patient and healthcare provider. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857869005017 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K903014 | 000 |