Massager
FDA 510(k) K944730 · North American Technical Services Corp.
510(k) numberK944730
Submission
- Device name
- Massager
- Applicant
- North American Technical Services Corp.
Sound Beach, NY, US - Received
- September 26, 1994
- Decision date
- February 14, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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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Questions and answers
When was Massager cleared by the FDA?
Massager (K944730) received a 510(k) decision of Substantially Equivalent for Some Indications on February 14, 1995, 141 days after the submission was received.
What is the product code of K944730?
The FDA product code is ISA – Massager, Therapeutic, Electric, a Class I (low risk) device regulated under 21 CFR 890.5660.