FDA Registration
Active
🇺🇸 United States
HARMONY HEALTH TECH INC
Reg #: 3037609256
·
FEI: 3037609256
·
Expires 2026
Products
13
Proprietary Names
11
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- HARMONY HEALTH TECH INC
- Registration Number
- 3037609256
- FEI Number
- 3037609256
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1414 Sheepshead Bay Rd, Ste 102
- City
- Brooklyn
- State
- NY
- ZIP
- 11235
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233067
Owner / Operator
- Firm Name
- Harmony Health Tech Inc
- Operator Number
- 10093795
- Address
- 1414 Sheepshead Bay Rd, Ste 102
- City
- Brooklyn
- State
- NY
- Postal Code
- 11235
- Country
- US
- Correspondent
- Marat Babakhanov
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2025-08-20 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2025-08-20 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2025-08-20 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2025-08-20 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2026-01-22 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2026-01-22 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2026-04-02 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2025-07-23 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2025-07-23 |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | IMI | Class 2 | Physical Medicine | No | 2025-08-20 |
| Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | PFW | Class 2 | Physical Medicine | No | 2025-08-20 |
| Orthosis, Limb, For Back Pain | PMV | Class 1 | Physical Medicine | No | 2025-08-20 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-08-20 |
Proprietary Names
Transcutaneous Electrical Nerve Stimulator, Joint Stimulator Model SM9116, SM9143
Cold Compression Therapy System
water sacculation, cold therapy system
Shijiazhuang Aofeite Medical Device Co., Ltd
Durable Medical Equipment (DME), Cold Compression Therapy System
Massage gun, Jet Spa
Ultrasound Device
Segments Pneumatic Equipment Compression Device
Bone Regrowth Stimulator; STIMULATOR, NERVE TRANSCUTANEOUS.OVER.THE-COUNTER ,FM-B2501,FM-B2503
PLT Laser Device
Infrared Mat, PEMF Mat
Establishment Types
Repack or Relabel Medical Device