Dual output digital therapy massager— 510(k) K172834
Substantially EquivalentShenzhen Osto Technology Co., Ltd.
FDA 510(k) clearance K172834 for Dual output digital therapy massager, Substantially Equivalent on 2018-09-06. Applicant: Shenzhen Osto Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Osto Technology Co., Ltd.
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code NUH
view all- K261131 — Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J +6 more
- K260412 — TENS 7000 Rechargeable 4 Channel (TENS 7000H)
- K260425 — TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
- K253896 — TENS/EMS device (GUSE01)
- K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
More clearances from Shenzhen Osto Technology Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.