Theracushion
FDA 510(k) K853710 · General Physiotherapy, Inc.
510(k) numberK853710
Submission
- Device name
- Theracushion
- Applicant
- General Physiotherapy, Inc.
St. Louis, MO, US - Received
- September 5, 1985
- Decision date
- January 3, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ISA – Massager, Therapeutic, Electric
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5660
- Specialty
- Physical Medicine
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More from Lpg One, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K870939 | VibracareISA · Traditional | 04/06/1987SE |
| K863383 | Facial Massager, Battery PoweredISA · Traditional | 09/15/1986SE |
| K861834 | Theracushion Model 1000ISA · Traditional | 05/27/1986SE |
| K855129 | Neocussor (Massager, Battery) PoweredBYI · Traditional | 01/23/1986SE |
| K852944 | Fleximatic MassagerISA · Traditional | 09/05/1985SE |
| K850047 | Sanyo Electronic Muscle StimulatorsIPF · Traditional | 03/05/1985SE |
| K844591 | Mist-Ease NebulizerCCQ · Traditional | 12/13/1984SE |
| K810244 | Porta-Puls Muscle StimulatorIRO · Traditional | 02/26/1981SE |
Questions and answers
When was Theracushion cleared by the FDA?
Theracushion (K853710) received a 510(k) decision of Substantially Equivalent on January 3, 1986, 120 days after the submission was received.
What is the product code of K853710?
The FDA product code is ISA – Massager, Therapeutic, Electric, a Class I (low risk) device regulated under 21 CFR 890.5660.