InCourage®

Vest, Size 48, Northern Lights

Registry build 21.09.26
1manufacturer
252catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Registered in Chongqing.

Chinese manufacturers registered for FDA product code BYI
Manufacturer City Province Registered as Device types
Chongqing Sonmol Technology Co., Ltd. Chongqing Chongqing Contract manufacturer 9

Record

Regulatory record for InCourage®
Listed by Respiratory Technologies, Inc., United States
FDA product code BYI
Device type Percussor, Powered-Electric
Device class Class 2
Regulation 21 CFR 868.5665
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K051383
Record published 2016-09-10
Record revised 2025-09-17 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number
Storage Storage environment temperature -25 to 85 °C
Sizes Circumference 16 to 60 in

Catalogue Numbers

Catalogue numbers for InCourage®
Catalogue number Size Status
100024-001 Circumference 24 in In distribution
100056-003 Circumference 56 in In distribution
100024-007 Circumference 24 in In distribution
137022-003 Large In distribution
100018-006 Circumference 18 in In distribution
100026-006 Circumference 26 in In distribution
100026-002 Circumference 26 in In distribution
100060-002 Circumference 60 in In distribution
100054-003 Circumference 54 in In distribution
100034-000 Circumference 34 in In distribution
100046-003 Circumference 46 in In distribution
137023-006 XLarge In distribution
100028-001 Circumference 28 in In distribution
100022-004 Circumference 22 in In distribution
100032-003 Circumference 32 in In distribution
100016-004 Circumference 16 in In distribution
100036-007 Circumference 36 in In distribution
100058-006 Circumference 58 in In distribution
100050-002 Circumference 50 in In distribution
100048-004 Circumference 48 in In distribution
100028-004 Circumference 28 in In distribution
100042-001 Circumference 42 in In distribution
100022-002 Circumference 22 in In distribution
100036-001 Circumference 36 in In distribution
100058-003 Circumference 58 in In distribution
100054-005 Circumference 54 in In distribution
100048-008 Circumference 48 in In distribution
100058-002 Circumference 58 in In distribution
100016-005 Circumference 16 in In distribution
100030-008 Circumference 30 in In distribution
100016-003 Circumference 16 in In distribution
100020-003 Circumference 20 in In distribution
100022-005 Circumference 22 in In distribution
100054-000 Circumference 54 in In distribution
100048-005 Circumference 48 in In distribution
100046-000 Circumference 46 in In distribution
100040-000 Circumference 40 in In distribution
100036-004 Circumference 36 in In distribution
100018-007 Circumference 18 in In distribution
100044-002 Circumference 44 in In distribution
100032-000 Circumference 32 in In distribution
100060-001 Circumference 60 in In distribution
100030-000 Circumference 30 in In distribution
100026-001 Circumference 26 in In distribution
137023-008 XLarge In distribution
100044-000 Circumference 44 in In distribution
137020-003 Small In distribution
100054-006 Circumference 54 in In distribution
100038-008 Circumference 38 in In distribution
100038-004 Circumference 38 in In distribution
137021-004 Medium In distribution
100042-004 Circumference 42 in In distribution
100042-007 Circumference 42 in In distribution
100020-005 Circumference 20 in In distribution
100058-001 Circumference 58 in In distribution
100040-001 Circumference 40 in In distribution
100042-008 Circumference 42 in In distribution
137020-005 Small In distribution
100028-007 Circumference 28 in In distribution
100034-004 Circumference 34 in In distribution
137020-001 Small In distribution
100040-008 Circumference 40 in In distribution
100040-002 Circumference 40 in In distribution
100056-007 Circumference 56 in In distribution
100058-000 Circumference 58 in In distribution
100040-005 Circumference 40 in In distribution
100048-007 Circumference 48 in In distribution
100044-003 Circumference 44 in In distribution
137022-005 Large In distribution
100050-007 Circumference 50 in In distribution
100046-008 Circumference 46 in In distribution
ICS-1M-US-B In distribution
137023-001 XLarge In distribution
100060-003 Circumference 60 in In distribution
100020-001 Circumference 20 in In distribution
100052-006 Circumference 52 in In distribution
137022-001 Large In distribution
100054-002 Circumference 54 in In distribution
ICS-1M-US-A In distribution
100054-007 Circumference 54 in In distribution
100056-002 Circumference 56 in In distribution
100060-000 Circumference 60 in In distribution
100034-005 Circumference 34 in In distribution
137022-007 Large In distribution
100034-003 Circumference 34 in In distribution
100060-006 Circumference 60 in In distribution
100024-003 Circumference 24 in In distribution
100018-008 Circumference 18 in In distribution
100052-003 Circumference 52 in In distribution
137020-007 Small In distribution
100044-008 Circumference 44 in In distribution
100028-005 Circumference 28 in In distribution
137020-000 Small In distribution
100038-003 Circumference 38 in In distribution
100056-001 Circumference 56 in In distribution
137023-005 XLarge In distribution
100056-000 Circumference 56 in In distribution
100044-007 Circumference 44 in In distribution
100032-006 Circumference 32 in In distribution
100030-002 Circumference 30 in In distribution
100044-005 Circumference 44 in In distribution
100024-006 Circumference 24 in In distribution
500040-001 In distribution
100046-002 Circumference 46 in In distribution
100052-007 Circumference 52 in In distribution
100022-006 Circumference 22 in In distribution
100040-003 Circumference 40 in In distribution
100038-006 Circumference 38 in In distribution
100052-000 Circumference 52 in In distribution
100050-008 Circumference 50 in In distribution
137023-003 XLarge In distribution
ICS-1M-US-A In distribution
100048-000 Circumference 48 in In distribution
100024-008 Circumference 24 in In distribution
137022-002 Large In distribution
100022-003 Circumference 22 in In distribution
137021-000 Medium In distribution
100022-000 Circumference 22 in In distribution
100048-006 Circumference 48 in In distribution
137023-007 XLarge In distribution
100020-006 Circumference 20 in In distribution
100018-004 Circumference 18 in In distribution
137020-002 Small In distribution
100020-008 Circumference 20 in In distribution
100056-008 Circumference 56 in In distribution
100050-006 Circumference 50 in In distribution
137023-004 XLarge In distribution
100036-008 Circumference 36 in In distribution
100020-007 Circumference 20 in In distribution
100030-004 Circumference 30 in In distribution
100026-005 Circumference 26 in In distribution
100028-002 Circumference 28 in In distribution
100034-007 Circumference 34 in In distribution
100040-006 Circumference 40 in In distribution
100044-006 Circumference 44 in In distribution
100038-007 Circumference 38 in In distribution
100022-008 Circumference 22 in In distribution
100016-008 Circumference 16 in In distribution
100030-005 Circumference 30 in In distribution
ICS-1M-US-A In distribution
100048-002 Circumference 48 in In distribution
100030-003 Circumference 30 in In distribution
ICS-1M-US-A In distribution
100034-002 Circumference 34 in In distribution
137022-004 Large In distribution
137022-006 Large In distribution
100036-000 Circumference 36 in In distribution
100034-006 Circumference 34 in In distribution
100022-007 Circumference 22 in In distribution
100042-005 Circumference 42 in In distribution
100032-001 Circumference 32 in In distribution
100028-008 Circumference 28 in In distribution
100028-000 Circumference 28 in In distribution
137021-005 Medium In distribution
100024-004 Circumference 24 in In distribution
100016-002 Circumference 16 in In distribution
100018-000 Circumference 18 in In distribution
100024-000 Circumference 24 in In distribution
100030-006 Circumference 30 in In distribution
100028-006 Circumference 28 in In distribution
100036-005 Circumference 36 in In distribution
100050-005 Circumference 50 in In distribution
100024-002 Circumference 24 in In distribution
100042-006 Circumference 42 in In distribution
137020-006 Small In distribution
100022-001 Circumference 22 in In distribution
100056-006 Circumference 56 in In distribution
100042-003 Circumference 42 in In distribution
137022-008 Large In distribution
100048-001 Circumference 48 in In distribution
100056-005 Circumference 56 in In distribution
100032-008 Circumference 32 in In distribution
ICS-1M-US In distribution
137021-001 Medium In distribution
137022-000 Large In distribution
100050-004 Circumference 50 in In distribution
100050-000 Circumference 50 in In distribution
100016-007 Circumference 16 in In distribution
137021-008 Medium In distribution
100060-007 Circumference 60 in In distribution
100036-003 Circumference 36 in In distribution
100018-003 Circumference 18 in In distribution
100026-007 Circumference 26 in In distribution
100046-005 Circumference 46 in In distribution
100028-003 Circumference 28 in In distribution
100054-008 Circumference 54 in In distribution
100060-004 Circumference 60 in In distribution
100036-006 Circumference 36 in In distribution
100020-002 Circumference 20 in In distribution
100032-005 Circumference 32 in In distribution
137021-006 Medium In distribution
100030-001 Circumference 30 in In distribution
100026-000 Circumference 26 in In distribution
100050-001 Circumference 50 in In distribution
100042-000 Circumference 42 in In distribution
100058-008 Circumference 58 in In distribution
100024-005 Circumference 24 in In distribution
100054-001 Circumference 54 in In distribution
100032-002 Circumference 32 in In distribution
100038-001 Circumference 38 in In distribution
500040-000 In distribution
137020-008 Small In distribution
100052-001 Circumference 52 in In distribution
100054-004 Circumference 54 in In distribution
100026-008 Circumference 26 in In distribution
100046-006 Circumference 46 in In distribution
100042-002 Circumference 42 in In distribution
100018-005 Circumference 18 in In distribution
100040-004 Circumference 40 in In distribution
100038-002 Circumference 38 in In distribution
100034-001 Circumference 34 in In distribution
100052-008 Circumference 52 in In distribution
100050-003 Circumference 50 in In distribution
100052-005 Circumference 52 in In distribution
100034-008 Circumference 34 in In distribution
100026-004 Circumference 26 in In distribution
100056-004 Circumference 56 in In distribution
100032-004 Circumference 32 in In distribution
100052-002 Circumference 52 in In distribution
100036-002 Circumference 36 in In distribution
ICS-1M-US-A In distribution
100030-007 Circumference 30 in In distribution
137021-007 Medium In distribution
100060-008 Circumference 60 in In distribution
100046-004 Circumference 46 in In distribution
100044-001 Circumference 44 in In distribution
100058-007 Circumference 58 in In distribution
100060-005 Circumference 60 in In distribution
100018-001 Circumference 18 in In distribution
100018-002 Circumference 18 in In distribution
100038-000 Circumference 38 in In distribution
137023-002 XLarge In distribution
100046-007 Circumference 46 in In distribution
100020-000 Circumference 20 in In distribution
100016-006 Circumference 16 in In distribution
100026-003 Circumference 26 in In distribution
100046-001 Circumference 46 in In distribution
137021-003 Medium In distribution
100058-005 Circumference 58 in In distribution
100048-003 Circumference 48 in In distribution
100058-004 Circumference 58 in In distribution
100032-007 Circumference 32 in In distribution
100038-005 Circumference 38 in In distribution
100040-007 Circumference 40 in In distribution
137023-000 XLarge In distribution
137020-004 Small In distribution
100052-004 Circumference 52 in In distribution
100044-004 Circumference 44 in In distribution
100020-004 Circumference 20 in In distribution
100016-000 Circumference 16 in In distribution

Showing 250 of 252 catalogue numbers.

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Showing 12 of 34. All products under Percussor, Powered-Electric

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K051383 2005-06-17

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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2,581device types they are registered for
340,248device records, each naming its maker
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