Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)
K211942 is the FDA 510(k) clearance record for Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B), a class II device, cleared for Shenzhen Osto Technology Company Limited on under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning). FDA's definition for product code NGX reads: "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...". FDA records list 12 510(k) clearances for Shenzhen Osto Technology Company Limited, from to . As of , FDA records show no recalls naming K211942.
Clearance record
- Decision date
- Received
- (173 days to decision)
- Product code
- NGX Stimulator, Muscle, Powered, For Muscle Conditioning
- Regulation
- 21 CFR 890.5850
- Device class
- Class II
- Review panel
- Physical Medicine
- Applicant
- Shenzhen Osto Technology Company Limited #43 Longfeng Rd., Xinsheng Community Longgang, Shenzhen, CN
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code NGX
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 1 |
| January 2026 | 1 |
| February 2026 | 0 |
| March 2026 | 1 |
| April 2026 | 1 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 1 |
| September 2026 | 0 |
| October 2026 | 0 |
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