510(k) K202045

Device: Imani I1
Applicant: Imani Co.
510(k) number: K202045
Product code: HGX
Decision: Substantially Equivalent (SESE)
Decision date: 2021-02-26
Date received: 2020-07-23
Regulation: 884.5160
Classification name: Pump, Breast, Powered
Medical specialty: Obstetrics/Gynecology
Review panel: Obstetrics/Gynecology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Hyo-Soon Hwang
Address: 1f, Na Dong, 19, Wanjangcheon-Ro 394beon-Gil, Namsa-Myeon, Cheoin-Gu Yongin-Si KR 17117 17117

FDA Registration Numbers

3030479957
3013513831
3012759464
3002807523
3043515178
3006774448
1423662
3028172072
3034993050
3005031124
3008138005
3024790242
3010834934
3013561139
3016871906
3030978471
3010626066
3009247326
3043165985
3008687634
1424785
1217805
3013684412
1721686
3014759586
3013053058
3016975995
3015200642
3029950834
3009243271
2435947
3021635975
3029833982
3021244152
3018159965
1419937
3026986849
3006446479
3006852457
3002297831
3009700166
3012605672
3009617411
3005210579
3017816623
3030671608
3012119286
3016693518
3029952735
3006610790
3008478778
3017196081
3010880718
3020848550
3013521677
3016245319
3039358595
3035371451
3012316249
3010308146
3008711096
3027841329
2110540
3006131984
1417592
3011800804
3003927385
3010334650
3003446042
3003509351
3007770329
2381321
3011191255
3038296449
3013699454
3003899230
9710641
3027115730
3009974348
3000126629

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DI	Brand	Company	Published
08800051100115	Powered breast pump	IMANI	2022-05-06
08800051100047	Powered breast pump	IMANI	2021-06-01

Other 510(k) Records For Product Code HGX

510(k)	Device	Applicant	Decision date
K254244	Wearable Breast Pump (Model S39)	Shenzhen TPH Technology Co., Ltd.	2026-05-21
K254125	Electric Breast Pump (HL-3058 II Pro)	Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.	2026-05-13
K253914	Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)	Shenzhen Root Innovation Technology Co., Ltd.	2026-04-29
K260239	Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)	Jiangxi AOV Maternity & Baby Products Co., Ltd.	2026-04-22
K253510	Freestyle Mini Hands-free	Medela, LLC	2026-04-10
K260033	Wearable Breast Pump (Model S21A)	Shenzhen TPH Technology Co., Ltd.	2026-04-08
K254258	Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D)	Shenzhen Root Innovation Technology Co., Ltd.	2026-04-08
K253946	Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)	Shenzhen Root Innovation Technology Co., Ltd.	2026-04-07
K250208	SPECTRA Wearable 2	Uzinmedicare Co., Ltd.	2026-04-06
K252744	Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)	Cixi Ruihong Electric Appliance Co., Ltd.	2026-04-03
K252583	Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)	A Cute Baby, Inc.	2026-03-12
K253934	Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)	Shenzhen Root Innovation Technology Co., Ltd.	2026-03-09
K253149	Motion InBra (YM-8801) wearable breast pump	Medela, LLC	2026-02-13
K252422	Wearable Breast Pump (Model W2)	Shenzhen TPH Technology Co., Ltd.	2026-02-13
K252420	Wearable Breast Pump (Model W12)	Shenzhen TPH Technology Co., Ltd.	2026-02-13

Legacy Summary

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