FDA Registration
Active
🇨🇳 China
SHENZHEN SUNGPO HI-TECH ELECTRONIC CO., LTD
Reg #: 3016071154
·
FEI: 3016071154
·
Expires 2026
Products
6
Proprietary Names
24
Establishment Types
4
Classifications
6
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Registration Details
- Registration Name
- SHENZHEN SUNGPO HI-TECH ELECTRONIC CO., LTD
- Registration Number
- 3016071154
- FEI Number
- 3016071154
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 318, Chuangke Building, 72-6 Huanguan South Road, Xintian Community, Guanhu Street, Longhua District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K230351
Owner / Operator
- Firm Name
- Shenzhen SUNGPO Hi-Tech Electronic Co., Ltd
- Operator Number
- 10062316
- Address
- Room 318, Chuangke Building, 72-6 Huanguan South Road, Xintian Community, Guanhu Street, Longhua District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518110
- Country
- CN
- Correspondent
- Yili Guo
US Agent
- Business Name
- BTS US Inc
- Contact Name
- Alex Gary
- Address
- 1624 Market St
- City
- Denver
- State
- CO
- ZIP
- 80202
- Country
- US
- [email protected]
- Phone
- 844 9823583
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2021-04-06 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-12-25 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2023-06-09 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2023-06-09 |
| Vibrator, Therapeutic | IRO | Class 1 | Physical Medicine | No | 2020-01-12 |
| Exerciser, Finger, Powered | JFA | Class 1 | Physical Medicine | No | 2024-08-02 |
Proprietary Names
[L33] SP-221, SP-219, SP-MG-048, SP-MG-049, SP-MG-050, SP-MG-051, SP-MG-052, SP-MG-053, 006CH, FT-006CH, FT-365
Massage Apparatus; brands: SUNGPO, SUNGHOT, CHOJOY; model(s): JMQ-BK-02
[L11] SP-MG-001, SP-MG-002, SP-MG-003, SP-MG-004, SP-MG-005, SP-MG-006, SP-MG-006A, SP-MG-006B, BN-PCA004
Massager; brands: SUNGPO, SUNGHOT, CHOJOY; model(s): see lines [L31-L33]
[L32] SP-E200, SP-E300, SP-ES-001, SP-ES-002, SP-ES-003, SP-ES-004, SP-ES-005, SP-ES-006
[L12] SP-MG-007, SP-MG-007A, SP-MG-007B, SP-MG-008, SP-MG-009, SP-MG-010, SP-MG-011, SP-MG-012, SP-MG-012A, SP-MG-012B
Massage Gun; brands: SUNGPO, SUNGHOT, CHOJOY; model(s): see lines [L11-L17]
[L31] SP-012, SP-012A, SP-012B, SP-015, SP-015-HDM, SP-168, SP-188, SP-218, SP-919-HDM, SP-E100, SP-E158, SP-E168
[L17] SP-25, SP-35, SP-15, SP-MG02, KS-001, KS-S002, ZB-003, TT-PCA005, TT-PCA006, TT-PCA007, G5, GM5
[L16] RF-GM168, RF-GM168BU, R-C004, I-MG001, I-MG002, I-MG003, S28, TT-PCA003, TT-PCA004, ZB-002, ZK-001, ZK-002
[L15] SP-MG-031, SP-MG-032, SP-MG-033, MG-101, MG-102, MG-103, MG-105, MG-106, MG-201, MG-202, MG-203, MG-205, MG-206
[L13] SP-MG-013, SP-MG-014, SP-MG-015, SP-MG-016, SP-MG-017, SP-MG-018, SP-MG-019, SP-MG-020
[L14] SP-MG-021, SP-MG-022, SP-MG-023, SP-MG-024, SP-MG-025, SP-MG-026, SP-MG-027, SP-MG-028, SP-MG-029, SP-MG-030
Light Therapy Shawl; model(s): SP-LS-501, SP-LS-502, SP-LS-503
Light Therapy Knee Pad; model(s): SP-KP-501, SP-KP-502, SP-KP-503
Light Therapy Ankle Sleeve; model(s): SP-AS-501, SP-AS-502, SP-AS-503
[L12] BK-RL-6685,SP-RL-501,SP-RL-502,SP-RL-503,SP-RL-504,SP-RL-505,SP-RL-506
Light Therapy Devices; model(s): see lines [L11-L12]
Light Therapy Glove; model(s): SP-LG-501, SP-LG-502, SP-LG-503
Light Therapy Neck Pad; model(s): SP-NP-501,SP-NP-502,SP-NP-503
[L11] SP-MG-053, SP-168, SP-188, SP-218, SP-219, SP-221, 006CH, FT-006CH, FT-365, SP-MG-053, SP-RL-511, SP-RL-512
Light Therapy Belt; model(s): SP-RB-501, SP-RB-502, SP-RB-503, SP-RB-504, SP-RB-505, SP-RB-506
LED Facial Mask; model(s): MZ-01, NEWKEY-01, SP-FM-01, ZK-01, SP-BM-561, SP-BM-562, SP-BM-563, SP-BM-564
Rehabilitation Robot Gloves, Finger Exerciser; model(s): SP-RG-001, SP-RG-002, SP-RG-100, RG21, SK21, SK21-2, SK22
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Foreign Private Label Distributor