FDA Registration
Active
🇨🇦 Canada
AIRWAY SURGICAL APPLIANCES LTD.
Reg #: 9611956
·
FEI: 1000213902
·
Expires 2026
Products
30
Proprietary Names
6
Establishment Types
3
Classifications
30
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Registration Details
- Registration Name
- AIRWAY SURGICAL APPLIANCES LTD.
- Registration Number
- 9611956
- FEI Number
- 1000213902
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 189 COLONNADE RD., SOUTH
- City
- NEPEAN Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K121106
Owner / Operator
- Firm Name
- SURGICAL APPLIANCE INDUSTRIES, INC.
- Operator Number
- 1511629
- Address
- 3960 ROSSLYN DR., --
- City
- Cincinnati
- State
- OH
- Postal Code
- 45209
- Country
- US
- Correspondent
- Richard J Stautberg
US Agent
- Business Name
- Surgical Appliance Industries, Inc.
- Contact Name
- James Stautberg
- Address
- 3960 ROSSLYN DRIVE
- City
- Cincinnati
- State
- OH
- ZIP
- 45209
- Country
- US
- [email protected]
- Phone
- 513 2714594
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2020-03-13 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 1992-08-04 |
| Cushion, Hemorrhoid | LRL | Class U | Unknown | No | 2016-06-09 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2007-08-02 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 1992-08-04 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2020-01-02 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 1992-08-04 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2007-08-02 |
| Support, Scrotal, Therapeutic | FQJ | Class 1 | General Hospital | No | 1992-08-04 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2007-08-02 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2007-08-02 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 1992-08-04 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2021-02-12 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2014-02-04 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 1992-08-04 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2022-04-28 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 1992-08-04 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2007-08-02 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2007-12-19 |
| Cane | IPS | Class 1 | Physical Medicine | No | 1992-08-04 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 1992-08-04 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 1992-08-04 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2014-02-04 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 1992-08-04 |
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2017-06-05 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 1992-08-04 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 1992-08-04 |
| Halter, Head, Traction | HSS | Class 1 | Orthopedic | No | 1992-08-04 |
| Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain | PQY | Class 2 | Physical Medicine | No | 2021-02-12 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2021-12-21 |
Proprietary Names
Champion CSX
Touch
Truform
PCP
OTC
Champion
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Manufacture Medical Device