FDA Registration
Active
🇧🇬 Bulgaria
BTL Industries JSC
Reg #: 3035374386
·
FEI: 3035374386
·
Expires 2026
Products
13
Proprietary Names
0
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- BTL Industries JSC
- Registration Number
- 3035374386
- FEI Number
- 3035374386
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Vladaya 3
- City
- Plovdiv
- Country
- BG
Regulatory Submissions
- 510(k) Number
- K193201
Owner / Operator
- Firm Name
- BTL INDUSTRIES LTD
- Operator Number
- 9071718
- Address
- 161 Cleveland Way, Stevenage
- City
- Hertfordshire
- State
- GB-HRT
- Postal Code
- SG1 6BU
- Country
- GB
US Agent
- Business Name
- BTL Industries Inc.
- Contact Name
- David Chmel
- Address
- 362 Elm St
- City
- Marlborough
- State
- MA
- ZIP
- 01752
- Country
- US
- [email protected]
- Phone
- 866 2851656 ext. 202
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2020-08-25 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2020-08-25 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2021-02-25 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | Class 2 | Neurology | No | 2025-02-21 |
| Table, Powered | INQ | Class 1 | Physical Medicine | No | 2009-05-31 |
| Transcranial Magnetic Stimulator | OBP | Class 2 | Neurology | No | 2022-12-15 |
| Electromagnetic Stimulator, Pain Relief | QPL | Class 2 | Neurology | No | 2026-01-14 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2021-06-10 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2018-12-14 |
| Stimulator, Muscle, Powered, Dental | NUW | Class 2 | Physical Medicine | No | 2025-08-21 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2024-09-19 |
| Vibrator, Therapeutic | IRO | Class 1 | Physical Medicine | No | 2016-03-01 |
| System, Isokinetic Testing And Evaluation | IKK | Class 2 | Physical Medicine | No | 2026-03-13 |
Establishment Types
Manufacture Medical Device