Little Wave Arc; Little Wave Flip
FDA 510(k) clearance K223533 · decided 2023-08-31
Clearance details
- K-number
- K223533
- Device name
- Little Wave Arc; Little Wave Flip
- Applicant
- Ki Mobility, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-11-23
- Decision date
- 2023-08-31
- Days to decision
- 281 days
- Clearance type
- Traditional
- Product code
- LBE
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Stevens Point, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PEDIATRIC FOLDING WHEELCHAIR (K130644) | Columbia Medical Mfg, LLC | 2013-10-16 |
| SULKY SPECIAL (K863450) | Asc Corp. | 1986-10-23 |
| PERAMBULATOR (STROLLER) (K862888) | Mednet, Inc. | 1986-08-13 |
| CARRIER (K840250) | Convaid Products, Inc. | 1984-02-09 |
| MECHANICAL CHAIR (K820591) | Kaye Products, Inc. | 1982-03-15 |
| CONVAID CRUISER CP4M (K810676) | Convaid Products, Inc. | 1981-03-26 |
| STROLLER, THERAPY (K781947) | Convaid Products, Inc. | 1978-12-04 |
Recalls involving this device
No recalls on record reference this clearance.