Koresway KB05
by Diversified Healthcare Development LLC. GUDID
Listed
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00008600088282 | Date22 Aug 2023 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Trade Name
- Koresway
- Generic Name
- Balance/cognitive function analysis system
- Model / Reference
- KB05
- Primary DI / UDI-DI
- 00008600088282
- FDA Product Code
- KHX
- GMDN Term
- Balance/cognitive function analysis system
- Device Class
- Class I
- Regulation Number
- 890.1575
- GUDID distribution status
- In Commercial Distribution
Other devices from Diversified Healthcare Development LLC.
Properties
Other properties (11)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No