# K211942: Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Osto Technology Company Limited
- Decided: Dec 13, 2021 after 173 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K940301 (1994). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190783: Health Expert Electronic Stimulator (model: AST-300L), Shenzhen Osto Technology Company Limited (2020) Summary page 4.
- K200561: StimPlus Patch, StimPlus Patch, StimPlus Patch, Jkh Health Co., Ltd. (2020) Summary page 5.

## Most influential descendants
- K223428: Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A) (2023), 0 descendants of its own

## Indications for use
PMS(1 ~ 2): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS(3 ~ 5): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm and leg due to strain from exercise or normal household work activities by applying current to stimulate nerve. Heating: The Heating Lumbar Therapy Cushion is intended for temporary relief of minor aches and pains.

Source page: https://510kreport.com/device/K211942
Methodology: https://510kreport.com/methodology