FDA Registration
Active
🇨🇳 China
SKG Health Technologies Co., LTD
Reg #: 3014601569
·
FEI: 3014601569
·
Expires 2026
Products
5
Proprietary Names
31
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- SKG Health Technologies Co., LTD
- Registration Number
- 3014601569
- FEI Number
- 3014601569
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 23A Floor,Building 3,Zhongke R & D Park,No. 009, Gaoxin South 1st Road,High-tech Zone Community,Yuehai str
- City
- Shen Zhen City Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K200558
Owner / Operator
- Firm Name
- SKG Health Technologies Co., LTD
- Operator Number
- 10083283
- Address
- 23A Floor,Building 3,Zhongke R & D Park,No. 009, Gaoxin South 1st Road,High-tech Zone Community,Yuehai str She
- City
- Shen Zhen City
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
- Correspondent
- ZHIMIN LIN
US Agent
- Business Name
- Simply Shipped, LLC
- Contact Name
- Mike Ryan
- Address
- 12745 W Townsend St
- City
- Brookfield
- State
- WI
- ZIP
- 53005
- Country
- US
- [email protected]
- Phone
- 414 3264114
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2021-11-08 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2025-12-09 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2022-03-01 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-08-21 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2026-04-09 |
Proprietary Names
Neck Massager:G7 Pro-Fold
Smart Neck Stimulator;K5-3EN
Smart Neck Stimulator;G7ProE
Smart Neck Stimulator;K6E
Smart Neck Stimulator;4356E
Smart Neck Stimulator;4098E
Smart Neck Stimulator; 4098 (RED)
Smart Neck Stimulator;K5pro
Massager Neck Tens;1014706
Neck Massager:G7 Pro-E
Neck Massager:G7Pro-Max
Neck Massager:GS500-N
Neck Massager:G7Pro Fold;G7Pro_Fold
Neck Massager:K5-3Pro
SKG Blood Pressure Monitor
SKG Bluetooth Blood Pressure Monitor
Body Massager :F7-E;F5-EN;F3 LITE;
Leg Massager;S1719HB
Mini Body Massager :F3-EN;
Knee Massager:W3 Pro,WS500;
Eye massager:E7-EN;E3 Pro;ES300;ES500;
Neck and shoulder massager:H5 Mini;H7 Max ;H7 Ultra ;H7 Ultra E;HS500-2;G7Pro_Fold
Massage Gun:X7-E;
Back & Neck Massager:T1-2Pro;
Waist Massager:W9Ultra;W9Pro
Foot Massager: YS100
SKG THERAPY DEVIC
Knee Massager: WS500
Waist Massager:W9Ultra
SKG Air Compression Leg Massager
SKG Leg Massager
Establishment Types
Manufacture Medical Device
Foreign Private Label Distributor
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device