FDA Registration
Active
🇺🇸 United States
SURGICAL APPLIANCE INDUSTRIES, INC.
Reg #: 1511629
·
FEI: 1511629
·
Expires 2026
Products
30
Proprietary Names
6
Establishment Types
4
Classifications
30
Registration Details
- Registration Name
- SURGICAL APPLIANCE INDUSTRIES, INC.
- Registration Number
- 1511629
- FEI Number
- 1511629
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3960 ROSSLYN DR.
- City
- CINCINNATI
- State
- OH
- ZIP
- 45209
- Country
- US
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 1992-08-04 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2014-01-16 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 1992-08-04 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2007-08-02 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2021-02-12 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 1992-08-04 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2022-04-28 |
| Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain | PQY | Class 2 | Physical Medicine | No | 2021-02-12 |
| Unit, Traction, Hip, Non-Powered, Non-Penetrating | HSR | Class 1 | Orthopedic | No | 1992-08-04 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2007-08-02 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2014-02-04 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2014-02-04 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 1977-12-26 |
| Halter, Head, Traction | HSS | Class 1 | Orthopedic | No | 1992-08-04 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 1992-08-04 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2007-08-02 |
| Support, Scrotal, Therapeutic | FQJ | Class 1 | General Hospital | No | 1992-08-04 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 1992-08-04 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 1992-08-04 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2014-02-04 |
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2017-06-05 |
| Accessories, Traction | ILZ | Class 1 | Physical Medicine | No | 1992-08-04 |
| Truss, Umbilical | EXM | Class 1 | Gastroenterology, Urology | No | 1992-08-04 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 1992-08-04 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2021-12-21 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2007-08-02 |
| Cage, Knee | ITM | Class 1 | Physical Medicine | No | 1992-08-04 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 1992-08-04 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 1992-08-04 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2007-08-02 |
Proprietary Names
OTC
Champion
Truform
PCP
Champion CSX
Touch
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198