Scout
by Burke, Inc.
510(k) K982158
Scout is a medical device (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Burke, Inc., cleared under FDA 510(k) K982158 on 31 Aug 1998, 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 | NumberK982158 | Date31 Aug 1998 | StatusActive |
Official records
- FDA 510(k) database K982158
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ITI
- Device class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K982158
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| PS Scout RF TPB | 82565 / RF TPB | B314825651 | — | On the market |
| Scout 4 P | 83181 / 4 P | B314831811 | — | On the market |
| Scout M-1 | 81445A / M-1 | B31481445A1 | — | On the market |
| Scout M-1 350 | 81855A / M-1 350 | B31481855A1 | — | On the market |
| Scout M-1 TPB | 82338 / M-1 TPB | B314823381 | — | On the market |
| Scout RF - SP | 81113A / RF - SP | B31481113A1 | — | On the market |
| Scout RF 4-P | 82554 / RF 4-P | B314825541 | — | On the market |
| Scout RF-P4 | 82491 / RF-P4 | B314824911 | — | On the market |
| Scout RF-P4 TPB-S | 83180 / RF-P4 TPB-S | B314831801 | — | On the market |
| Scout RF-P4 W/S | 83173 / RF-P4 W/S | B314831731 | — | On the market |
| Scout RF4 | 81122 / RF4 | B314811221 | — | On the market |
Similar devices
Other devices filed under FDA product code ITI (Wheelchair, Powered).
- e-fix E35/E36 by Alber GmbH
- EXTREME 4X4-X8 POWER WHEELCHAIR by Vestil Manufacturing Corp.
- BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair by 21ST CENTURY SCIENTIFIC, INC.
- Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820) by Soul Mobility
- PEGASUS PROACTIVE WHEELCHAIR CUSHION by Pegasus Airwave, Inc.
- SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP by Eurogreen International Inc.
- ASL MODEL #104 by ADAPTIVE SWITCH LABORATORIES, INC.
- AMYSEAT TILT/RECLINE SEATING by Amysystems
- CRUISER by Invacare Corp.
- OC3 FLYER by Intl. Medical Equipment Corp.