FDA Registration
Active
🇺🇸 United States
Champion MFG, INC.
Reg #: 1027229
·
FEI: 1027229
·
Expires 2026
Products
7
Proprietary Names
51
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Champion MFG, INC.
- Registration Number
- 1027229
- FEI Number
- 1027229
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5516 SW 1st Ln
- City
- Ocala
- State
- FL
- ZIP
- 34474
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152056
Owner / Operator
- Firm Name
- Champion Mfg, Inc.
- Operator Number
- 10055089
- Address
- 5516 SW 1st Ln
- City
- Ocala
- State
- FL
- Postal Code
- 34474
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chair, Blood Donor | FML | Class 1 | General Hospital | No | 2021-12-16 |
| Stretcher, Wheeled, Powered | INK | Class 2 | Physical Medicine | No | 2021-12-16 |
| Chair, Geriatric | FRJ | Class 1 | General Hospital | No | 2021-12-16 |
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2021-12-16 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2021-12-16 |
| Chair, Surgical, Ac-Powered | GBB | Class 1 | General, Plastic Surgery | No | 2017-06-05 |
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2017-06-05 |
Proprietary Names
Blood Drawing Chair
XL Padded Blood Drawing Chair
Designer Blood Drawing Chair
Padded Blood Drawing Chair
S550 Stretchair
Care Cliner
Elite Comfort Recliner
Home Care-Cliner
XL Convalescent Recliner
Convalescent Recliner
Premier Lifecare Recliner
Elite Care Cliner
Drop Arm Convalescent Recliner
Inverness 24 Hour Treatment Recliner
Designer Care Cliner
Lifecare Recliner
Premier Care Cliner
Stretchair MC675CL
Stretchair S750
Stretchair S675
Recovery Alo Straight Back Power (61PL)
Augustine 5001
Ascent II (67P Series), Ascent II XL (68P Series), Ascent XL (66P Series)
Recovery Alo Wing Back Power (63PL)
54P Series, 56P Series, 58P Series, 59P Series, 85P Series, 86P Series, 89P Series, Ascent (65P Series)
Recovery Alo Wing Back XL Power (64PL
Alo XL Straight Back (62P series)
Recovery Alo Straight Back XL Manual (620L)
Alo Wing Back (63P Series)
Recovery Alo Straight Back XL Power (62PL)
Recovery Alo Straight Back Manual (610L)
Vero
Recovery Alo Wing Back Manual (630L)
Alo Straight Back (61P Series)
Alo XL Wing Back (64P Series)
Recovery Alo Wing Back XL Manual (640L)
Unity Treatment (310 Series); Unity Treatment Wide (31X Series)
Unity Clinical (310 Series); Unity Clinical Wide (31X Series)
S400
TMM5 chair
TMM 4 PLUS chair
TMM5 PLUS chair
TMM 3 chair
TMM4 chair
T3, T4, T5
Alo Straight Back (61 Series)
Alo Wing Back (63 Series)
Alo XL Wing Back (64 Series)
54 Series, 56 Series, 58 Series, 59 Series, 85 Series, 86 Series, 89 Series, Ascent (65 Series), Ascent II (67 Series),
Alo XL Straight Back (62 Series)
Ascent II XL (68 Series), Ascent XL (66 Series)
Establishment Types
Manufacture Medical Device