FDA Registration
Active
🇫🇷 France
SUBLIMED
Reg #: 3015588280
·
FEI: 3015588280
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- SUBLIMED
- Registration Number
- 3015588280
- FEI Number
- 3015588280
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 137 Rue Mayoussard
- City
- Moirans Auvergne-Rhone-Alpes
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K252767
Owner / Operator
- Firm Name
- SUBLIMED
- Operator Number
- 10088953
- Address
- 137 Rue Mayoussard
- City
- Moirans
- State
- Auvergne-Rhone-Alpes
- Postal Code
- 38380
- Country
- FR
- Correspondent
- Adrien HALLET
US Agent
- Business Name
- Medical Device Academy Incorporated
- Contact Name
- Robert Packard
- Address
- 345 Lincoln Hill Rd
- City
- Cuttingsville
- State
- VT
- ZIP
- 05738
- Country
- US
- [email protected]
- Phone
- 802 2581881
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2026-04-24 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2026-04-24 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2026-04-24 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2026-04-24 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2026-04-24 |
Proprietary Names
actiTENS mini spare
actiTENS mini Textile Accessory
actiTENS mini KIT
actiTENS iOs app
actiTENS Android app
self-adhesive strip
actiTENS Standard Kit
actiTENS spare
Charging Case spare
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device