510(k) K772271
- Device
- WALKER FOLDING ADJUSTABLE
- Applicant
- MEDFUSION SYSTEMS, INC.
- 510(k) number
- K772271
- Product code
- ITQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-12-20
- Date received
- 1977-12-09
- Regulation
- 890.3475
- Classification name
- Joint, Knee, External Brace
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1058152
- 1058311
- 3009437400
- 3030446844
- 3008754100
- 2429947
- 2245519
- 3014301596
- 3043654665
- 9613910
- 3014658541
- 3007774549
- 3008395114
- 3038636181
- 3016219840
- 3011536935
- 3045853560
- 3016414923
- 3013613278
- 3030175335
- 3014060494
- 1522875
- 3016000973
- 3016758972
- 1000649241
- 1054236
- 3010961310
- 3013198248
- 3003981946
- 3006801236
- 3017619379
- 3014579161
- 3032062344
- 3008951115
- 9612388
- 1016498
- 1422443
- 3005869201
- 3006400320
- 3033519
- 3043140679
- 3014663650
- 3012841710
- 3011363045
- 3021594345
- 3008247697
- 3043149162
- 3014144875
- 3011678115
- 3010043561
- 3007218972
- 3034205725
- 1057079
- 3014599232
- 3014943293
- 3010508273
- 3005190268
- 3045857302
- 3040274588
- 3016872092
- 1000626221
- 3016468151
- 3021550083
- 2953713
- 3015142701
- 3005083016
- 3024891479
- 3003855936
- 3009206505
- 3014690514
- 3017449291
- 3005533873
- 1063974
- 2950684
- 3042227943
- 3014826829
- 3013180212
- 3010260768
- 3008808082
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ITQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K831044 | LIMITED MOTION FUNCTIONAL KNEE BRACE | Orthopedic Systems, Inc. | 1983-06-24 |
| K831310 | BRACE C.T. | Innovation Sports, Inc. | 1983-05-16 |
| K823658 | DELUXE KNEE IMMOBILIZER(UNIVERSAL) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| K823397 | ANATOMIC FRACTURE BRACE | Orthopedic Systems, Inc. | 1982-11-29 |
| K823159 | DELUXE KNEE IMMOBILIZER | Warm & Form, Orthopedic Materials | 1982-11-10 |
| K812423 | NEOPRENE KNEE SUPPORT | Surgical Appliance Industries, Inc. | 1981-09-14 |
| K812094 | AIRCAST PNEUMATIC KNEE BRACE | Aircast, Inc. | 1981-08-13 |
| K811689 | CYLINDER KNEE CAST/SPLINT | Surgical Appliance Industries, Inc. | 1981-06-25 |
| K810222 | LIMB ORHTOSIS | Medical Design & Manufacturing Corp. | 1981-02-04 |
| K802673 | KNEE BRACE/STABILIZER | Omni Scientific, Inc. | 1980-11-12 |
| K780892 | FRACTURE BRACING | Hosmer Dorrance Corp. | 1978-06-13 |
| K772268 | DEMI-WALKER (REGULAR) | Med Fusion Systems, Inc. | 1977-12-20 |
| K772269 | SETUP WALKER ADJUSTABLE | Med Fusion Systems, Inc. | 1977-12-20 |
| K772270 | SETUP WALKER OVER TOILET CONSTRUC. | Med Fusion Systems, Inc. | 1977-12-20 |
Legacy Summary#
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FDA Review#
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