Karma Wheelchair
510(k) K950195
Karma Wheelchair is a medical device (FDA Class I; FDA product code IOR, Wheelchair, Mechanical) made by Karman Healthcare, Inc., cleared under FDA 510(k) K950195 on 7 Mar 1995, 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 | NumberK950195 | Date7 Mar 1995 | StatusActive |
Official records
- FDA 510(k) database K950195
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- Withdrawn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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- KAIYANG ALUMINUM WHEELCHAIR by Guangdong Kaiyang Medical Technology Co., Ltd.
- TILITE AERO X by Tisport
- Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) by ANHUI JBH MEDICAL APPARATUS CO., LTD
- POIRIER KID-ROLLER MANUAL WHEELCHAIR by Roseburg SA
- Flexx Junior (FLX-J00, FLX-J50) by Karma Mobility Co, Ltd.
- KAIYANG STEEL WHEELCHAIR by Guangdong Kaiyang Medical Technology Co., Ltd.
- COMPETITOR by Kuschall of America
- MYCYCLE, HANDMASTER, VICTORY by Richvale, Ltd.
- CHUMP by Colours 'N Motion