Wearable Breast Pump (Model S36)
Shenzhen TPH Technology Co., Ltd. · Obstetrics/Gynecology
Open FDA's page for this record- Third party flag
- N
- City
- Shenzhen
- Advisory committee description
- Obstetrics/Gynecology
- Address 1
- Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology
- Address 2
- Park, # 21 Bulan Rd., Xialilang Community, Nanwan St.
- Statement or summary
- Summary
- Product code
- HGX
- Zip code
- 518000
- Applicant
- Shenzhen TPH Technology Co., Ltd.
- Decision date
- 2026-09-17
- Decision code
- SESE
- Country code
- CN
- Device name
- Wearable Breast Pump (Model S36)
- Advisory committee
- OB
- Contact
- Dale Wang
- K number
- K254203
- Date received
- 2025-12-29
- Review advisory committee
- OB
- Postal code
- 518000
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Pump, Breast, Powered
- Medical specialty description
- Obstetrics/Gynecology
- Regulation number
- 884.5160
- Device class
- 2
- Registration number
- 3013513831, 1417592, 3016915446, 3009974348, 3013521677, 3038613158, 3010626066, 3015501220, 3007491602, 3018159965, 3031566471, 3035371451, 3016562061, 3013684412, 3011191255, 3008711096, 3030479957, 3013561139, 3012759464, 3010334650, 3020305857, 2435947, 3012684779, 3002589861, 3020994856, 3017816623, 3016975995, 1424785, 3009243271, 3021376102, 3034993050, 3016871906, 3005031124, 3021635975, 3006131984, 3011077581, 3020848550, 3031841858, 3020119717, 3029923636 +77 more
- FEI number
- 3013513831, 1417592, 3016915446, 3009974348, 3003565456, 3013521677, 3038613158, 3010626066, 3015501220, 3007491602, 3018159965, 3031566471, 3035371451, 3016562061, 3013684412, 3011191255, 3008711096, 3030479957, 3013561139, 3012759464, 3010334650, 3020305857, 3012684779, 3002589861, 3020994856, 3017816623, 3016975995, 3009243271, 3000215273, 3021376102, 3034993050, 3016871906, 3005031124, 3021635975, 3006131984, 3011077581, 3020848550, 3031841858, 3020119717, 3029923636 +77 more