← FDA Medical Device Classifications

Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

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

Classification

FDA Product Code

ILX

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

N

Market data

Cleared 510(k) submissions

15

Registered establishments

7

Source

Authoritative

FDA Device Classification database

Machine

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