Limb Orhtosis
FDA 510(k) K810222 · Medical Design & Manufacturing Corp.
510(k) numberK810222
Submission
- Device name
- Limb Orhtosis
- Applicant
- Medical Design & Manufacturing Corp.
Walker, MI, US - Received
- January 27, 1981
- Decision date
- February 4, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ITQ – Joint, Knee, External Brace
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Specialty
- Physical Medicine
Other 510(k)s with product code ITQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831044 | Limited Motion Functional Knee BraceITQ · Traditional | Orthopedic Systems, Inc. | 06/24/1983SE |
| K831310 | Brace C.T.ITQ · Traditional | Innovation Sports, Inc. | 05/16/1983SE |
| K823658 | Deluxe Knee Immobilizer(Universal)ITQ · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823397 | Anatomic Fracture BraceITQ · Traditional | Orthopedic Systems, Inc. | 11/29/1982SE |
| K823159 | Deluxe Knee ImmobilizerITQ · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
| K812423 | Neoprene Knee SupportITQ · Traditional | Surgical Appliance Industries, Inc. | 09/14/1981SE |
| K812094 | Aircast Pneumatic Knee BraceITQ · Traditional | Aircast, Inc. | 08/13/1981SE |
| K811689 | Cylinder Knee Cast/SplintITQ · Traditional | Surgical Appliance Industries, Inc. | 06/25/1981SE |
| K802673 | Knee Brace/StabilizerITQ · Traditional | Omni Scientific, Inc. | 11/12/1980SE |
| K780892 | Fracture BracingITQ · Traditional | Hosmer Dorrance Corp. | 06/13/1978SE |
More from Hosmer Dorrance Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K911911 | Medical Designs, Inc. Bio-Therapy SystemHCC · Traditional | 03/20/1992SE |
| K914384 | Medical Designs Reusable Carbon Rubber ElectrodeGXY · Traditional | 11/13/1991SE |
| K911366 | Protector Disposable TENS and Nmes ElectrodeGXY · Traditional | 09/27/1991SE |
| K902822 | Medical Designs, Inc., Spectrum II TENS DeviceGZJ · Traditional | 12/19/1990SE |
| K895604 | Soft-Ez Reusable Self-Adhering Pigtail ElectrodesGXY · Traditional | 10/13/1989SE |
| K880492 | Intercept T.E.N.S. DeviceGZJ · Traditional | 04/18/1988SE |
| K834138 | Hypo SutureGAG · Traditional | 01/27/1984SE |
| K821848 | Assure-Male External Incontince CatheterKNX · Traditional | 08/10/1982SE |
| K811224 | MinistimGZJ · Traditional | 06/02/1981SE |
Questions and answers
When was Limb Orhtosis cleared by the FDA?
Limb Orhtosis (K810222) received a 510(k) decision of Substantially Equivalent on February 4, 1981, 8 days after the submission was received.
What is the product code of K810222?
The FDA product code is ITQ – Joint, Knee, External Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.