← FDA Medical Device Classifications

Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

IMJ · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5290

Classification

FDA Product Code

IMJ

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 890.5290

Review panel

PM

Medical specialty

Physical Medicine

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

44

Registered establishments

14

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown