510(k) clearances

Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)

Sichuan Qianli-Beoka Medical Technology, Inc. · Physical Medicine

K243206Substantially EquivalentTraditionalIRP
Open FDA's page for this record
Third party flag
N
City
Chengdu
Advisory committee description
Physical Medicine
Address 1
Longtan Industrial Park 2nd Sec, E. 3rd Ring Rd.
Address 2
Chenghua District
Statement or summary
Summary
Product code
IRP
Zip code
610052
Applicant
Sichuan Qianli-Beoka Medical Technology, Inc.
Decision date
2025-02-19
Decision code
SESE
Country code
CN
Device name
Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)
Advisory committee
PM
Contact
Qiuju Cai
K number
K243206
Date received
2024-10-01
Review advisory committee
PM
Postal code
610052
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Massager, Powered Inflatable Tube
Medical specialty description
Physical Medicine
Regulation number
890.5650
Device class
2
Registration number
2424387, 1000548922, 2028253, 3009955851, 1222630, 3010201075, 9611425, 3011654863, 3012651177, 3014606355, 3038295706, 3033648890, 3010894709, 3009942828, 3021594313, 3011539161, 3002849858, 3009437400, 3015228371, 3019849074, 3008902816, 3013787796, 3017150671, 3011767724, 3016452327, 3004727093, 3033435469, 3035781155, 3012176966, 3014159202, 3004126239, 1832894, 3011684767, 3023215120, 9680425, 3013733364, 3018383120, 3012289707, 3012365608, 3018109879 +61 more
FEI number
2424387, 1000548922, 3009955851, 3010201075, 3011654863, 3012651177, 3014606355, 3038295706, 3033648890, 3010894709, 3009942828, 3021594313, 3011539161, 3002849858, 3009437400, 3015228371, 3019849074, 3008902816, 3013787796, 3017150671, 3011767724, 3016452327, 3004727093, 3033435469, 3035781155, 3012176966, 3014159202, 3004126239, 1832894, 3011684767, 3023215120, 3013733364, 1000120897, 3018383120, 3012289707, 3012365608, 3018109879, 3032062344, 3002865632, 3016910466 +61 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.