Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H— 510(k) K210756
Substantially EquivalentShenzhen Osto Technology Company Limited
FDA 510(k) clearance K210756 for Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H, Substantially Equivalent on 2021-06-11. Applicant: Shenzhen Osto Technology Company Limited. Device class: 2.
Clearance details
- Applicant
- Shenzhen Osto Technology Company Limited
- Product code
- Product 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 Company Limited
view all- K213056 — LED Facial Mask
- K211942 — Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
- K211736 — Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
- K190783 — Health Expert Electronic Stimulator (model: AST-300L)
- K190673 — Health Expert Electronic Stimulator
Data sourced from openFDA. This site is unofficial and independent of the FDA.