FDA Registration
Active
🇺🇸 United States
K2 HEALTH PRODUCTS
Reg #: 3007220726
·
FEI: 3007220726
·
Expires 2026
Products
10
Proprietary Names
2
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- K2 HEALTH PRODUCTS
- Registration Number
- 3007220726
- FEI Number
- 3007220726
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5377 Kings Hwy
- City
- Brooklyn
- State
- NY
- ZIP
- 11203
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182640
Owner / Operator
- Firm Name
- K2 Health Products
- Operator Number
- 10027056
- Address
- 5377 kings highway
- City
- Brooklyn
- State
- NY
- Postal Code
- 11203
- Country
- US
- Correspondent
- Moshe Klerer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2010-12-15 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-10-19 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2023-10-19 |
| Cushion, Wheelchair | IMP | Class 1 | Physical Medicine | No | 2010-12-15 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-03 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2011-10-10 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2010-12-15 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2012-11-06 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2025-08-18 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2010-12-15 |
Proprietary Names
kolbs
Inspire
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility