Helio
510(k) K120628
Helio is a medical device (FDA Class I; FDA product code IOR, Wheelchair, Mechanical) made by Motion Composites, cleared under FDA 510(k) K120628 on 19 Dec 2012, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120628 | Date19 Dec 2012 | StatusActive |
Official records
- FDA 510(k) database K120628
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IOR
- Device class
- Class I
- Regulation
- 21 CFR Part 890.3850
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code IOR (Wheelchair, Mechanical).
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- Athena 190 by MEDICAL REHAB PRODUCTS, LLC
- Manual Wheelchair by Jiangyin Newrise Medical Equipment Co., Ltd.