A & I WHEELCHAIRS
FDA 510(k) clearance K010094 · decided 2001-02-15
Clearance details
- K-number
- K010094
- Device name
- A & I WHEELCHAIRS
- Applicant
- Taiwan an I Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-01-11
- Decision date
- 2001-02-15
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Chia-Yi Shiann, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.