Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
FDA 510(k) K211942 · Shenzhen Osto Technology Company Limited
Submission
- Device name
- Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
- Applicant
- Shenzhen Osto Technology Company Limited
Shenzhen, CN - Received
- June 23, 2021
- Decision date
- December 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGX – Stimulator, Muscle, Powered, For Muscle Conditioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this…
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| 510(k) | Device | Decision |
|---|---|---|
| K213056 | LED Facial MaskOLP · Traditional | 07/07/2022SE |
| K212989 | Low-frequency Stimulator (Model: AST-645, AST-646)NUH · Traditional | 11/22/2021SE |
| K211736 | Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V…NUH · Traditional | 09/05/2021SE |
| K210756 | Neck Care Therapy, Model: AST-905A, AST-905D, AST-905HNUH · Traditional | 06/11/2021SE |
| K190783 | Health Expert Electronic Stimulator (model: AST-300L)NUH · Traditional | 03/14/2020SE |
| K190673 | Health Expert Electronic StimulatorNUH · Traditional | 12/12/2019SE |
| K182136 | Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)NUH · Traditional | 10/10/2019SE |
| K172897 | Neck Care Therapy, Model: SYK 509BNUH · Traditional | 12/07/2018SE |
| K172837 | Low-frequency Multi-function physiotherapy instrumentNUH · Traditional | 11/26/2018SE |
| K172834 | Dual output digital therapy massagerNUH · Traditional | 09/06/2018SE |
Questions and answers
When was Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) cleared by the FDA?
Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) (K211942) received a 510(k) decision of Substantially Equivalent on December 13, 2021, 173 days after the submission was received.
What is the product code of K211942?
The FDA product code is NGX – Stimulator, Muscle, Powered, For Muscle Conditioning, a Class II (moderate risk) device regulated under 21 CFR 890.5850.