510(k) K191159
- Device
- Concentrator With Single Battery Pack, Carry Bag With Shoulder Strap, Back Pack Shoulder Straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory For Use On IOS And Android Devices, Invacare Platinum Mobile Oxygen Conc
- Applicant
- Invacare Corporation
- 510(k) number
- K191159
- Product code
- CAW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-08-29
- Date received
- 2019-05-01
- Regulation
- 868.5440
- Classification name
- Generator, Oxygen, Portable
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Elijah Wreh
- Address
- One Invacare Way Elyria OH US 44035 44035
FDA Registration Numbers#
- 3010440667
- 9710644
- 3008507279
- 3011249646
- 2085602
- 3013095415
- 3000126629
- 3002807637
- 3023245116
- 3005569927
- 1039215
- 3023272766
- 2032532
- 3007220521
- 1000604079
- 3009096682
- 3012316249
- 3018783526
- 1419185
- 3007307467
- 1319044
- 3007344957
- 3016859940
- 3004672275
- 3008910673
- 3011191255
- 2183615
- 3027241818
- 3003803075
- 3025889185
- 3014661487
- 3011767915
- 3033814505
- 3037045878
- 3005873568
- 3009128734
- 3020476987
- 3007573469
- 3013000203
- 3011895992
- 3017825461
- 3033526676
- 3011205710
- 3008841036
- 3043460907
- 2515872
- 3003207908
- 3017520736
- 3014777423
- 2523148
- 2028807
- 3004964590
- 3006991053
- 1924066
- 3015142815
- 3001400310
- 3005803793
- 9611451
- 3032013079
- 3011120183
- 3042507287
- 3004112621
- 3006534178
- 3010317211
- 3043648593
- 3016809216
- 3008220943
- 3005587132
- 3003637574
- 2518422
- 3014810929
- 3029227324
- 3004972304
- 1220477
- 3033859527
- 3006240053
- 3017684630
- 3009683397
- 3009550619
Source Documents#
Other 510(k) Records For Product Code CAW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252965 | Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. | 2026-05-29 |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | 2026-04-23 |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | 2026-03-26 |
| K251534 | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. | 2025-12-29 |
| K252616 | Portable oxygen concentrator (JLO-190P) | Shenzhen Homed Medical Device Co., Ltd. | 2025-12-22 |
| K251764 | Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025-12-22 |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | 2025-12-16 |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Devilbiss Healthcare, LLC | 2025-12-09 |
| K251607 | Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co., Ltd. | 2025-11-21 |
| K243833 | Portable oxygen concentrator (JAY-1000P) | Longfian Scitech Co., Ltd. | 2025-09-29 |
| K250625 | Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) | Nanjing Yinuoji Medical Technology Co., Ltd. | 2025-08-27 |
| K251130 | Portable Oxygen Concentrator (JM-P50A) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2025-08-21 |
| K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort) | Caire, Inc. | 2025-07-11 |
| K242736 | Portable Oxygen Concentrator (Spirit-3) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-06-05 |
| K242718 | Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025-02-28 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases