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510(k) K211942

Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) by Shenzhen Osto Technology Company Limited — Product Code NGX

K211942 is an FDA 510(k) premarket notification submitted by Shenzhen Osto Technology Company Limited for the device "Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)". The FDA issued a decision of Substantially Equivalent on December 13, 2021. The device falls under product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning), a Class II device regulated under 21 CFR 890.5850. Shenzhen Osto Technology Company Limited has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2021
Date Received
June 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

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 device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.

Other clearances by Shenzhen Osto Technology Company Limited

  • K213056 — LED Facial Mask (July 7, 2022)
  • K211736 — Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST (September 5, 2021)
  • K210756 — Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H (June 11, 2021)
  • K190783 — Health Expert Electronic Stimulator (model: AST-300L) (March 14, 2020)
  • K190673 — Health Expert Electronic Stimulator (December 12, 2019)
  • K133929 — HEALTH EXPERT ELCTRONIC STIMULATOR (November 12, 2014)

Other clearances for product code NGX

  • K253926 — Diacore (April 10, 2026)
  • K253636 — Zionic Pro Max (EMS) (March 12, 2026)
  • K253408 — CoolTone (January 16, 2026)
  • K252154 — Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-232 (December 9, 2025)
  • K253478 — Motive™ Muscle Stimulator for Lower Back (OT01-1003) (November 6, 2025)
  • K251594 — truFlex (August 28, 2025)
  • K251706 — TENS and EMS Unit (July 30, 2025)
  • K251378 — CoolTone (July 14, 2025)
  • K251746 — Pure Impact (July 2, 2025)
  • K250759 — 3 in 1 TENS UNIT (June 13, 2025)

FDA data resources