Orthoderm Convertible
FDA 510(k) K894353 · Health Products, Inc.
510(k) numberK894353
Submission
- Device name
- Orthoderm Convertible
- Applicant
- Health Products, Inc.
Houston, TX, US - Received
- July 14, 1989
- Decision date
- August 9, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IOQ – Bed, Flotation Therapy, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5170
- Specialty
- Physical Medicine
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|---|---|---|
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| K911807 | Metered Dose Inhaler (Mdi) SpacerCAF · Traditional | 10/23/1991SE |
| K902292 | Modified Assess(R) Peak Flow MeterBZH · Traditional | 08/10/1990SE |
| K896953 | Modified Assess(R) Peak Flow MeterBZH · Traditional | 01/30/1990SE |
| K890426 | Consummate Air Therapy BedFNL · Traditional | 04/05/1989SE |
| K874801 | Orthoderm Therapy BedFNM · Traditional | 02/05/1988SE |
| K871742 | Modified Use of Plex Inspiratory Muscle TrainerBWF · Traditional | 06/15/1987SE |
| K870514 | Threshold(Tm) Inspiratory Muscle TrainerBWF · Traditional | 03/31/1987SE |
| K864719 | Pflex Em(Tm) (Exercise Monitor)BWF · Traditional | 03/16/1987SE |
Questions and answers
When was Orthoderm Convertible cleared by the FDA?
Orthoderm Convertible (K894353) received a 510(k) decision of Substantially Equivalent on August 9, 1989, 26 days after the submission was received.
What is the product code of K894353?
The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.